Neurocrine Biosciences Reports Third Quarter 2025 Financial Results

Achieved Total Net Product Sales of $790 Million Representing 28% Year-Over-Year Growth

INGREZZA^® (valbenazine) Third-Quarter 2025 Net Product Sales of $687 Million Representing 12% Year-Over-Year Growth

CRENESSITY^® (crinecerfont) Third-Quarter 2025 Net Product Sales of $98 Million
with 540 Total New Patient Enrollment Start Forms

SAN DIEGO, Oct. 28, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the third quarter ended September 30, 2025.

"Neurocrine's third quarter commercial results highlight the meaningful impact that INGREZZA and CRENESSITY are having on patients' lives. INGREZZA achieved another record quarter in new patient starts and total prescriptions, further demonstrating continued unmet need within the tardive dyskinesia and Huntington's chorea market. CRENESSITY's strong launch reflects its status as a first-in-class therapy that is changing standard of care treatment for patients with classic congenital adrenal hyperplasia," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With registration-enabling clinical trials enrolling for osavampator in major depressive disorder and direclidine in schizophrenia, Neurocrine Biosciences is well positioned to lead the next wave of innovation in neuroscience, advancing transformative therapies that meaningfully improve the lives of patients."

Net Product Sales Highlights

• Total net product sales for the third-quarter 2025 were $790 million, reflecting 16% sequential growth over the second quarter of 2025 and 28% growth year-over-year.
• INGREZZA net product sales for the third-quarter 2025 were $687 million, reflecting 10% sequential growth over the second quarter of 2025 and 12% growth year-over-year. Double-digit volume growth was driven by strong patient demand, including record quarterly new and total prescriptions.
• CRENESSITY net product sales for the third-quarter 2025 were $98 million and included 540 total new patient enrollment start forms reflecting strong patient demand with 80% reimbursement coverage for dispensed scripts.
• CRENESSITY net product sales through the first nine months of 2025 were $166 million and included 1,617 total new patient enrollment forms.

Recent Clinical and Corporate Developments

• Initiated second Phase 3 registrational clinical trial for direclidine, an oral muscarinic M4 selective orthosteric agonist, as a potential treatment for adults with schizophrenia.
• Presented new data from the Phase 2 SAVITRI™ study, which showed statistically significant and clinically meaningful improvement in depression severity at Day 28 and Day 56 with once-daily oral administration of 1 mg osavampator. In recognition of the data presentation, the Company was honored with the 2025 Poster Award at the 38^th annual Psych Congress in San Diego.
• Presented new data from a post-hoc analysis of the Phase 4 KINECT-PRO™ open-label study confirming that robust rates of symptomatic remission of tardive dyskinesia were achieved with once-daily INGREZZA capsules. The analysis also showed sustained improvements in patient-reported outcomes among participants who achieved symptomatic remission.
• Presented new data from the open-label KINECT^®-HD2 study demonstrating an established long-term safety profile, tolerability and sustained improvements in chorea severity through three years of treatment with once-daily INGREZZA capsules in adults with Huntington's disease.
• Announced the appointment of Mike Sibley as Senior Vice President and General Manager of the company's Neuropsychiatry franchise. Mr. Sibley, a proven leader with more than 20 years of commercial experience in the biopharmaceutical industry, will be responsible for developing and executing the sales and marketing strategy for Neurocrine's neuropsychiatry products, including the INGREZZA franchise.
• Announced planned expansion of the INGREZZA and CRENESSITY sales teams to maximize commercial momentum. Expansion to be completed by the end of the first quarter of 2026.
• Company to host R&D Day in San Diego on December 16, 2025.

Third Quarter 2025 Financial Results

• Differences in third quarter 2025 GAAP and Non-GAAP operating expenses compared with third 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 related headcount and launch activities and continued investment in INGREZZA, including the expansion of the psychiatry and long-term care sales teams in September 2024.
• Third quarter 2025 GAAP net income and earnings per share were $210 million and $2.04, respectively, compared with $130 million and $1.24, respectively, for third quarter 2024.
• Third quarter 2025 Non-GAAP net income and earnings per share were $222 million and $2.17, respectively, compared with $189 million and $1.81, respectively, for third quarter 2024.
• Differences in third quarter 2025 GAAP and Non-GAAP net income compared with third quarter 2024 were primarily driven by:
  • Higher net product sales of $173 million
  • Increased operating expenses in support of expanding and advancing R&D portfolio, incremental investment in CRENESSITY launch activities, and continued investment in INGREZZA, including the expansion of the psychiatry and long-term care sales teams in September 2024
  • Third quarter 2025 includes $1 million expense for development milestones achieved under collaborations, compared with $39 million for third quarter 2024
  • Third quarter 2025 includes $31 million gain from changes in fair values of equity investments, compared with a loss of $17 million for third quarter 2024 (Non-GAAP adjustment)
• At September 30, 2025, the Company had cash, cash equivalents, and marketable securities totaling approximately $2.1 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.

Reaffirmed Full Year 2025 INGREZZA Guidance and Updated Financial Guidance

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 800-274-8461 (US) or 203-518-9814 (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 www.neurocrine.com. 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 neuroscience-focused, 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 neuropsychiatric, neurological, and neuroendocrine 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 and Facebook. (*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, and 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, 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: 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 CRENESSITY; our financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; 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; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 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.

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SOURCE Neurocrine Biosciences, Inc.