Full Press Release Details
INGREZZA ® (valbenazine) First-Quarter 2025 Net Product Sales of $545 Million and Reaffirms 2025 Net Product Sales Guidance of $2.5 - $2.6 Billion
CRENESSITY TM (crinecerfont) First-Quarter 2025 Net Product Sales of $14.5 Million with 413 Total Patient Enrollment Start Forms
Initiated Phase 3 Registrational Programs for Osavampator in Major Depressive Disorder and NBI-'568 in Schizophrenia to Position for Next Phase of Growth
SAN DIEGO , May 5, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the first quarter ended March 31, 2025, and reaffirms its 2025 financial guidance.
"We delivered a record number of new patient starts for INGREZZA, which is especially impressive given the typically challenging first quarter. This strong performance gives us good momentum heading into the rest of the year. We are reaffirming 2025 INGREZZA net sales guidance of $2.5 to $2.6 billion ," said Kyle W. Gano , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "For CRENESSITY, we are encouraged by the initial launch and the positive receptivity among the congenital adrenal hyperplasia community. The combination of INGREZZA and CRENESSITY provides a solid foundation for near- and long-term revenue growth."
"With registrational programs for osavampator and NBI-'568 ongoing, an advancing early-to-mid-stage pipeline, and a strong balance sheet, Neurocrine is well positioned to deliver sustained growth and innovation in neuroscience," added Dr. Gano.
First-Quarter 2025 Net Product Sales Highlights
Recent Clinical and Corporate Developments
First Quarter 2025 Financial Results
| Three Months Ended March 31, | |||
| (unaudited, in millions, except per share data) | 2025 | 2024 | |
| Revenues: | |||
| INGREZZA Net Product Sales | $ 545.2 | $ 506.0 | |
| CRENESSITY Net Product Sales | 14.5 | — | |
| Other Revenues | 12.9 | 9.3 | |
| Total Revenues | $ 572.6 | $ 515.3 | |
| GAAP Research and Development (R&D) | $ 263.2 | $ 159.4 | |
| Non-GAAP R&D | $ 240.2 | $ 142.4 | |
| GAAP Selling, General, and Administrative (SG&A) | $ 276.5 | $ 243.1 | |
| Non-GAAP SG&A | $ 245.3 | $ 215.6 | |
| GAAP Net Income | $ 7.9 | $ 43.4 | |
| GAAP Earnings Per Share – Diluted | $ 0.08 | $ 0.42 | |
| Non-GAAP Net Income | $ 71.5 | $ 124.8 | |
| Non-GAAP Earnings Per Share – Diluted | $ 0.70 | $ 1.20 | |
| (unaudited, in millions) | March 31, 2025 | December 31, 2024 | |
| Total Cash, Cash Equivalents, and Marketable Securities | $ 1,758.8 | $ 1,815.6 |
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 Financial Guidance
| Range | |||
| (in millions) | Low | High | |
| INGREZZA Net Product Sales 1 | $ 2,500 | $ 2,600 | |
| GAAP R&D Expense 2 | $ 960 | $ 1,010 | |
| Non-GAAP R&D Expense 2, 3 | $ 890 | $ 940 | |
| GAAP SG&A Expense 4 | $ 1,110 | $ 1,130 | |
| Non-GAAP SG&A Expense 3, 4 | $ 955 | $ 975 |
| 1. | INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. |
| 2. | R&D guidance reflects the continued advancement of the Company's pre-clinical and clinical portfolio including the initiation of Phase 3 programs for osavampator in MDD and NBI-568 in schizophrenia. R&D guidance includes $60 million of expense for development milestones primarily in connection with collaborations with Takeda and Nxera that were achieved or deemed probable to achieve. Acquired in-process research and development expense is included in guidance once significant collaboration and licensing arrangements have been completed. |
| 3. | Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $85 million in R&D and $115 million in SG&A 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. |
| 4. | SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth and the launch of CRENESSITY. |
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 800-245-3047 (US) or 203-518-9765 (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, and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. CRENESSITY is a trademark 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
| TABLE 1 NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) | |||
| Three Months Ended March 31, | |||
| (in millions, except per share data) | 2025 | 2024 | |
| Revenues: | |||
| Net product sales | $ 563.7 | $ 509.0 | |
| Collaboration revenue | 8.9 | 6.3 | |
| Total revenues | 572.6 | 515.3 | |
| Operating expenses: | |||
| Cost of revenues | 9.2 | 7.5 | |
| Research and development | 263.2 | 159.4 | |
| Acquired in-process research and development | 0.1 | 6.0 | |
| Selling, general, and administrative | 276.5 | 243.1 | |
| Total operating expenses | 549.0 | 416.0 | |
| Operating income | 23.6 | 99.3 | |
| Other (expense) income: | |||
| Unrealized (loss) gain on equity investments | (30.6) | 1.6 | |
| Charges associated with convertible senior notes | — | (88.7) | |
| Investment income and other, net | 21.7 | 22.3 | |
| Total other expense, net | (8.9) | (64.8) | |
| Income before provision for income taxes | 14.7 | 34.5 | |
| Provision for (benefit from) income taxes | 6.8 | (8.9) | |
| Net income | $ 7.9 | $ 43.4 | |
| Earnings per share, basic | $ 0.08 | $ 0.43 | |
| Earnings per share, diluted | $ 0.08 | $ 0.42 | |
| Weighted average common shares outstanding, basic | 99.7 | 99.8 | |
| Weighted average common shares outstanding, diluted | 102.5 | 103.6 |
| TABLE 2 NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) | |||
| (in millions) | March 31, 2025 | December 31, 2024 | |
| Cash, cash equivalents, and marketable securities | $ 943.5 | $ 1,076.1 | |
| Other current assets | 694.4 | 648.6 | |
| Total current assets | 1,637.9 | 1,724.7 | |
| Deferred tax assets | 499.4 | 485.7 | |
| Marketable securities | 815.3 | 739.5 | |
| Right-of-use assets | 502.2 | 509.4 | |
| Equity investments | 94.2 | 124.8 | |
| Property and equipment, net | 87.0 | 82.6 | |
| Intangible assets, net | 36.4 | 36.5 | |
| Other noncurrent assets | 15.3 | 15.5 | |
| Total assets | $ 3,687.7 | $ 3,718.7 | |
| Current liabilities | $ 522.9 | $ 507.7 | |
| Noncurrent operating lease liabilities | 447.5 | 455.1 | |
| Other noncurrent liabilities | 181.6 | 166.2 | |
| Stockholders' equity | 2,535.7 | 2,589.7 | |
| Total liabilities and stockholders' equity | $ 3,687.7 | $ 3,718.7 |
| TABLE 3 NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) | |||
| Three Months Ended March 31, | |||
| (in millions, except per share data) | 2025 | 2024 | |
| GAAP net income 1 | $ 7.9 | $ 43.4 | |
| Adjustments: | |||
| Stock-based compensation expense - R&D | 23.0 | 17.0 | |
| Stock-based compensation expense - SG&A | 29.8 | 27.5 | |
| Charges associated with convertible senior notes 2 | — | 88.7 | |
| Vacated legacy campus facility costs, net of sublease income 3 | 1.4 | — | |
| Non-cash amortization related to acquired intangible assets | 1.0 | 0.9 | |
| Changes in fair values of equity investments 4 | 30.6 | (1.6) | |
| Other | — | 0.2 | |
| Income tax effect related to reconciling items 5 | (22.2) | (51.3) | |
| Non-GAAP net income 1 | $ 71.5 | $ 124.8 | |
| Diluted earnings per share: | |||
| GAAP | $ 0.08 | $ 0.42 | |
| Non-GAAP | $ 0.70 | $ 1.20 |
| 1. | Three months ended March 31, 2025 and 2024 reflect $45.4 million and $6.1 million, respectively, of expense for development milestones achieved under collaborations. Three months ended March 31, 2025 and 2024 reflect $0.1 million and $6.0 million, respectively, of IPR&D expense related to payments of upfront fees in connection with collaborations. |
| 2. | Reflects charges associated with the settlement of convertible senior notes conversions. |
| 3. | Reflects impairment charges and other costs associated with our vacated legacy campus facilities, net of sublease income, as we transition to occupy our new campus facility. |
| 4. | Reflects periodic fluctuations in the fair values of equity investments. |
| 5. | Estimated income tax effect of Non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance and adjustments to exclude tax benefits or expenses associated with charges associated with convertible senior notes and non-cash stock-based compensation. |
| TABLE 4 NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP EXPENSES (unaudited) | |||
| Three Months Ended March 31, | |||
| (in millions) | 2025 | 2024 | |
| GAAP cost of revenues | $ 9.2 | $ 7.5 | |
| Adjustments: | |||
| Non-cash amortization related to acquired intangible assets | 1.0 | 0.9 | |
| Non-GAAP cost of revenues | $ 8.2 | $ 6.6 | |
| Three Months Ended March 31, | |||
| (in millions) | 2025 | 2024 | |
| GAAP R&D | $ 263.2 | $ 159.4 | |
| Adjustments: | |||
| Stock-based compensation expense | 23.0 | 17.0 | |
| Non-GAAP R&D | $ 240.2 | $ 142.4 | |
| Three Months Ended March 31, | |||
| (in millions) | 2025 | 2024 | |
| GAAP SG&A | $ 276.5 | $ 243.1 | |
| Adjustments: | |||
| Stock-based compensation expense | 29.8 | 27.5 | |
| Vacated legacy campus facility costs, net of sublease income | 1.4 | — | |
| Non-GAAP SG&A | $ 245.3 | $ 215.6 | |
| Three Months Ended March 31, | |||
| (in millions) | 2025 | 2024 | |
| GAAP other expense, net | $ (8.9) | $ (64.8) | |
| Adjustments: | |||
| Charges associated with convertible senior notes | — | 88.7 | |
| Changes in fair values of equity investments | 30.6 | (1.6) | |
| Other | — | 0.2 | |
| Non-GAAP other income, net | $ 21.7 | $ 22.5 |
SOURCE Neurocrine Biosciences, Inc.