Full Press Release Details
INGREZZA ® (valbenazine) Fourth Quarter and Full Year 2024 Net Product Sales of $615 Million and $2.3 Billion , Representing Year-Over-Year Growth of 23% and 26% Respectively
INGREZZA ® (valbenazine) Full Year 2025 Net Product Sales Guidance of $2.5 - $2.6 Billion
CRENESSITY TM (crinecerfont), a First-in-Class Treatment for Children and Adults with Classic Congenital Adrenal Hyperplasia, Approved and Launched in the United States
Phase 3 Programs for Osavampator in Major Depressive Disorder and NBI-'568 in Schizophrenia Initiating in the First Half of 2025
SAN DIEGO , Feb. 6, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the fourth quarter and full year ended December 31, 2024 and provided financial guidance for 2025.
"I'm proud of the tremendous progress we made last year with the continued growth of INGREZZA for patients living with tardive dyskinesia or Huntington disease chorea. With the approval and launch of CRENESSITY, we look forward to delivering the first new treatment for the congenital adrenal hyperplasia community in over 70 years, transforming the standard of care for patients," said Kyle W. Gano , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With a rapidly advancing and growing pipeline and a strong financial profile, we are well positioned to build a leading neuroscience company."
Financial Highlights
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (unaudited, in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
| Revenues: | |||||||
| Net Product Sales | $ 621.2 | $ 507.2 | $ 2,330.6 | $ 1,860.6 | |||
| Collaboration Revenue | 6.5 | 8.0 | 24.7 | 26.5 | |||
| Total Revenues | $ 627.7 | $ 515.2 | $ 2,355.3 | $ 1,887.1 | |||
| GAAP Research and Development (R&D) | $ 185.6 | $ 137.5 | $ 731.1 | $ 565.0 | |||
| Non-GAAP R&D | $ 164.4 | $ 124.3 | $ 662.3 | $ 497.0 | |||
| GAAP Selling, General, and Administrative (SG&A) | $ 287.8 | $ 218.9 | $ 1,007.2 | $ 887.6 | |||
| Non-GAAP SG&A | $ 241.6 | $ 194.0 | $ 862.5 | $ 757.4 | |||
| GAAP Net Income | $ 103.1 | $ 147.7 | $ 341.3 | $ 249.7 | |||
| GAAP Earnings Per Share – Diluted | $ 1.00 | $ 1.44 | $ 3.29 | $ 2.47 | |||
| Non-GAAP Net Income | $ 173.4 | $ 157.7 | $ 656.3 | $ 390.0 | |||
| Non-GAAP Earnings Per Share – Diluted | $ 1.69 | $ 1.54 | $ 6.33 | $ 3.86 | |||
| (unaudited, in millions) | December 31, 2024 | December 31, 2023 | |||||
| Total Cash, Cash Equivalents, and Marketable Securities | $ 1,815.6 | $ 1,719.1 |
Net Product Sales Highlights
Other Key Financial Highlights
Recent Developments
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 our pre-clinical and clinical portfolio including the initiation of our 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 our collaborations with Takeda and Nxera 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 $70 million in R&D and $130 million in SG&A and vacated legacy campus facility costs. |
| 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 800-225-9448 (US) or 203-518-9708 (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 (Formerly Twitter) 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, acquisition and integration costs, 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.
| TABLE 1 NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) | |||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
| Revenues: | |||||||
| Net product sales | $ 621.2 | $ 507.2 | $ 2,330.6 | $ 1,860.6 | |||
| Collaboration revenue | 6.5 | 8.0 | 24.7 | 26.5 | |||
| Total revenues | 627.7 | 515.2 | 2,355.3 | 1,887.1 | |||
| Operating expenses: | |||||||
| Cost of revenues | 9.3 | 8.5 | 34.0 | 39.7 | |||
| Research and development | 185.6 | 137.5 | 731.1 | 565.0 | |||
| Acquired in-process research and development | 3.0 | — | 12.5 | 143.9 | |||
| Selling, general, and administrative | 287.8 | 218.9 | 1,007.2 | 887.6 | |||
| Total operating expenses | 485.7 | 364.9 | 1,784.8 | 1,636.2 | |||
| Operating income | 142.0 | 150.3 | 570.5 | 250.9 | |||
| Other income (expense): | |||||||
| Unrealized (loss) gain on equity investments | (1.9) | 29.0 | (37.1) | 28.4 | |||
| Charges associated with convertible senior notes | — | — | (138.4) | — | |||
| Investment income and other, net | 22.5 | 18.9 | 91.0 | 52.8 | |||
| Total other income (expense), net | 20.6 | 47.9 | (84.5) | 81.2 | |||
| Income before provision for income taxes | 162.6 | 198.2 | 486.0 | 332.1 | |||
| Provision for income taxes | 59.5 | 50.5 | 144.7 | 82.4 | |||
| Net income | $ 103.1 | $ 147.7 | $ 341.3 | $ 249.7 | |||
| Earnings per share, basic | $ 1.03 | $ 1.50 | $ 3.40 | $ 2.56 | |||
| Earnings per share, diluted | $ 1.00 | $ 1.44 | $ 3.29 | $ 2.47 | |||
| Weighted average common shares outstanding, basic | 100.0 | 98.4 | 100.4 | 97.7 | |||
| Weighted average common shares outstanding, diluted | 102.9 | 102.3 | 103.7 | 101.0 |
| TABLE 2 NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) | |||
| (in millions) | December 31, 2024 | December 31, 2023 | |
| Cash, cash equivalents, and marketable securities | $ 1,076.1 | $ 1,031.6 | |
| Other current assets | 648.6 | 575.4 | |
| Total current assets | 1,724.7 | 1,607.0 | |
| Deferred tax assets | 485.7 | 362.6 | |
| Marketable securities | 739.5 | 687.5 | |
| Right-of-use assets | 509.4 | 276.5 | |
| Equity investments | 124.8 | 161.9 | |
| Property and equipment, net | 82.6 | 70.8 | |
| Intangible assets, net | 36.5 | 35.5 | |
| Other noncurrent assets | 15.5 | 49.6 | |
| Total assets | $ 3,718.7 | $ 3,251.4 | |
| Convertible senior notes | $ — | $ 170.1 | |
| Other current liabilities | 507.7 | 484.7 | |
| Total current liabilities | 507.7 | 654.8 | |
| Noncurrent operating lease liabilities | 455.1 | 258.3 | |
| Other noncurrent liabilities | 166.2 | 106.3 | |
| Stockholders' equity | 2,589.7 | 2,232.0 | |
| Total liabilities and stockholders' equity | $ 3,718.7 | $ 3,251.4 |
| TABLE 3 NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) | |||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
| GAAP net income 1 | $ 103.1 | $ 147.7 | $ 341.3 | $ 249.7 | |||
| Adjustments: | |||||||
| Stock-based compensation expense - R&D | 21.2 | 13.2 | 68.8 | 68.0 | |||
| Stock-based compensation expense - SG&A | 45.2 | 24.9 | 126.7 | 126.3 | |||
| Charges associated with convertible senior notes 2 | — | — | 138.4 | — | |||
| Vacated legacy campus facility costs, net of sublease income 3 | 1.0 | — | 18.0 | — | |||
| Non-cash amortization related to acquired intangible assets | 0.9 | 0.8 | 3.6 | 3.5 | |||
| Changes in fair values of equity investments 4 | 1.9 | (29.0) | 37.1 | (28.4) | |||
| Other | — | 0.1 | 0.3 | 4.6 | |||
| Income tax effect related to reconciling items 5 | 0.1 | — | (77.9) | (33.7) | |||
| Non-GAAP net income 1 | $ 173.4 | $ 157.7 | $ 656.3 | $ 390.0 | |||
| Diluted earnings per share: | |||||||
| GAAP | $ 1.00 | $ 1.44 | $ 3.29 | $ 2.47 | |||
| Non-GAAP | $ 1.69 | $ 1.54 | $ 6.33 | $ 3.86 |
| 1. | Twelve months ended December 31, 2024 reflect $71.7 million of expense for development milestones achieved under collaborations and $12.5 million of IPR&D expense for payments of upfront fees. Twelve months ended December 31, 2023 reflect $143.9 million of IPR&D expense related to expansion of strategic partnership with Voyager Therapeutics, Inc. |
| 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 December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2024 | 2023 | 2024 | 2023 | |||
| GAAP cost of revenues | $ 9.3 | $ 8.5 | $ 34.0 | $ 39.7 | |||
| Adjustments: | |||||||
| Non-cash amortization related to acquired intangible assets | 0.9 | 0.8 | 3.6 | 3.5 | |||
| Non-GAAP cost of revenues | $ 8.4 | $ 7.7 | $ 30.4 | $ 36.2 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2024 | 2023 | 2024 | 2023 | |||
| GAAP R&D | $ 185.6 | $ 137.5 | $ 731.1 | $ 565.0 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 21.2 | 13.2 | 68.8 | 68.0 | |||
| Non-GAAP R&D | $ 164.4 | $ 124.3 | $ 662.3 | $ 497.0 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2024 | 2023 | 2024 | 2023 | |||
| GAAP SG&A | $ 287.8 | $ 218.9 | $ 1,007.2 | $ 887.6 | |||
| Adjustments: | |||||||
| Stock-based compensation expense | 45.2 | 24.9 | 126.7 | 126.3 | |||
| Vacated legacy campus facility costs, net of sublease income | 1.0 | — | 18.0 | — | |||
| Other | — | — | — | 3.9 | |||
| Non-GAAP SG&A | $ 241.6 | $ 194.0 | $ 862.5 | $ 757.4 | |||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
| (in millions) | 2024 | 2023 | 2024 | 2023 | |||
| GAAP other income (expense), net | $ 20.6 | $ 47.9 | $ (84.5) | $ 81.2 | |||
| Adjustments: | |||||||
| Charges associated with convertible senior notes | — | — | 138.4 | — | |||
| Changes in fair values of equity investments | 1.9 | (29.0) | 37.1 | (28.4) | |||
| Other | — | 0.1 | 0.3 | 0.7 | |||
| Non-GAAP other income, net | $ 22.5 | $ 19.0 | $ 91.3 | $ 53.5 |
SOURCE Neurocrine Biosciences, Inc.