Valbenazine Tosylate

Total Fourth-Quarter and Full-Year 2025 Net Product Sales of $798.3 Million and $2.83 Billion, Representing Year-Over-Year Growth of 29% and 22%, Respectively INGREZZA® (valbenazine) Full Year 2026 Net Product Sales Guidance of $2.7 - $2.8 Billion SAN DIEGO, Feb. 11, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the fourth quarter ended December 31, 2025. "Our 2025 performance reflects the strength and durability of our commercial business and meaningful progress we are making transforming Neurocrine into a broader, more diversified biopharmaceutical company," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2026, we are focused on delivering strong, sustainable growth for INGREZZA and CRENESSITY® (crinecerfont) while advancing our pipeline anchored by Phase 3 programs, including osavampator in major depressive disorder and direclidine in schizophrenia. We expect this building momentum will create value for all stakeholders as Neurocrine is well positioned to improve the lives of even more patients in the years ahead." Net Product Sales Highlights Total fourth-quarter and full-year 2025 net product sales were $798.3 million and $2.83 billion, reflecting 29% and 22% growth year-over-year, respectively. INGREZZA fourth-quarter and full-year 2025 net product sales were $657.5 million and $2.51 billion, reflecting 7% and 9% growth year-over-year, respectively. Results reflected double-digit prescription volume growth in TRx and NRx driven by strong patient demand, partially offset by a lower net price due to new formulary access investments to support long-term growth. CRENESSITY fourth-quarter and full-year 2025 net product sales were $135.3 million and $301.2 million, reflecting 431 and 2,048 total new patient enrollment start forms, respectively, driven by strong patient demand with over 80% reimbursement coverage for dispensed scripts in the fourth-quarter. Recent Clinical and Corporate Developments Published a landmark narrative review on FDA-approved vesicular monoamine transporter 2 (VMAT2) inhibitors demonstrating the unique profile of INGREZZA in CNS Spectrums. The review highlighted the distinct profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concluded that VMAT2 inhibitors are not clinically interchangeable. Presented head-to-head INGREZZA capsules data at the American College of Neuropsychopharmacology 64th Annual Meeting showing a nearly two-fold higher VMAT2 mean target occupancy, consistent with greater potency when compared to AUSTEDO XR (deutetrabenazine) after a single dose. In addition, the lowest approved dose of INGREZZA (40 mg) exhibited higher estimated VMAT2 target occupancy at steady state versus the highest approved dose of AUSTEDO XR (48 mg) at steady state. At Neurocrine's R&D Day in December, provided an update on Neurocrine's R&D engine, which remains on track to deliver multiple first- and best-in-class medicines across an industry-leading neuropsychiatry portfolio, including Phase 3 programs for osavampator in major depressive disorder and direclidine in schizophrenia. Neurocrine remains well-positioned for long-term value creation across core therapeutic areas and announced the strategic expansion and diversification of the corticotropin releasing factor (CRF) platform as a foundation for a new class of medicines targeting metabolic diseases, including obesity. Announced the initiation of a Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of VMAT2. Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD. Fourth-Quarter and Full-Year 2025 Financial Results Differences in fourth-quarter 2025 GAAP and Non-GAAP operating expenses compared with fourth-quarter 2024 were driven by: Increased R&D expense in support of an expanded and advancing pre-clinical and clinical portfolio including investments in osavampator Phase 3 program in major depressive disorder (MDD) and muscarinic franchise, including the direclidine Phase 3 program as a potential treatment for adults with schizophrenia. Increased SG&A expense including incremental investment in CRENESSITY launch activities and continued investment in INGREZZA. Increased acquired in-process research and development (IPR&D) expense associated with upfront payments for early-stage development candidates license agreements Fourth-quarter 2025 GAAP net income and earnings per share were $153.7 million and $1.48, respectively, compared with $103.1 million and $1.00, respectively, for fourth-quarter 2024. Fourth-quarter 2025 Non-GAAP net income and earnings per share were $194.6 million and $1.88, respectively, compared with $173.4 million and $1.69, respectively, for fourth-quarter 2024. Differences in fourth-quarter 2025 GAAP and Non-GAAP net income compared with fourth-quarter 2024 were primarily driven by: Higher net product sales of $177.1 million Increased operating expenses in support of expanding and advancing R&D portfolio, incremental investment in CRENESSITY launch activities, and continued investment in INGREZZA Increased IPR&D expense associated with upfront payments for early-stage development candidates license agreements At December 31, 2025, the Company had cash, cash equivalents, and marketable securities totaling approximately $2.54 billion. A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 and Table 4 at the end of this news release. Full-Year 2026 Financial Guidance INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. R&D guidance reflects the continued advancement of the Company's pre-clinical and clinical portfolio including the Phase 3 programs for osavampator in MDD and direclidine in schizophrenia, and includes approximately $25 million of expense for development milestones related to our in-licensed product candidates. Development milestones are included in R&D guidance once achieved or deemed probable to achieve. Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of approximately $90 million in R&D and $125 million in SG&A, divestiture-related expenses and vacated legacy campus facility costs. Non-cash stock-based compensation expense for performance-based equity awards is included in guidance once the predefined performance-based criteria for vesting is achieved or deemed probable to achieve. IPR&D guidance represents completed collaboration and licensing arrangements. SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth and the launch of CRENESSITY including expansion of sales teams expected to be completed by the end of the first quarter of 2026. Conference Call and Webcast Today at 4:30 PM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-579-2543 (US) or 785-424-1789 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 4:30 p.m. Eastern Time on Neurocrine Biosciences' website under Investors at . A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neuropsychiatric, neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes U.S. FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following Non-GAAP financial measures: Non-GAAP R&D expense, Non-GAAP SG&A expense, Non-GAAP operating income, Non-GAAP net income and net income per share. When preparing the Non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these Non-GAAP financial measures exclude: non-cash stock-based compensation expense, charges associated with convertible senior notes, vacated legacy campus facility costs, net of sublease income, non-cash amortization expense related to acquired intangible assets, changes in fair value of equity investments, transaction and divestiture-related expenses, changes in foreign currency exchange rates and certain adjustments to income tax expense. These Non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these Non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these Non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a Non-GAAP basis. A reconciliation of these GAAP financial results to Non-GAAP financial results is included in the attached financial information. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our business strategy, objectives, and future development plans; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully launching and commercializing CRENESSITY; our financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; clinical and scientific data updates for our products and product candidates, including observations regarding clinical outcomes, safety, and tolerability; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements, include but are not limited to the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general; risks and uncertainties associated with the commercialization of INGREZZA and CRENESSITY; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. SOURCE Neurocrine Biosciences, Inc. 21% more press release views with Request a Demo

SAN DIEGO, Jan. 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of the vesicular monoamine transporter 2 (VMAT2). Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD. "NBI-'890 is an internally discovered molecule with distinct physical and chemical properties that may allow it to benefit a broader range of patients with tardive dyskinesia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Advancing this program to a Phase 2 clinical study is key to our strategy to define the future of VMAT2 biology and deliver lasting impact for patients." This Phase 2, randomized, double-blind, placebo-controlled study will enroll approximately 100 adult subjects with TD and will assess the efficacy, safety, and tolerability of NBI-1065890 compared with placebo. The primary efficacy endpoint is change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of Items 1–7) at Week 8. Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease. For more information about the Phase 2 study (NBI-1065890-TD2033), visit ClinicalTrials.gov. About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About NBI-1065890 NBI-1065890, discovered and developed internally at Neurocrine, is a potent, selective and orally bioavailable inhibitor of vesicular monoamine transporter 2 (VMAT2) in clinical development for the treatment of tardive dyskinesia (TD). Inhibition of VMAT2 is expected to provide therapeutic benefit in TD, other hyperkinetic movement disorders, and potentially other CNS disorders where dopaminergic signaling is dysregulated. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES logo, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the efficacy and therapeutic potential of NBI-1065890. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended September 30, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. SOURCE Neurocrine Biosciences, Inc. 21% more press release views with Request a Demo