Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2024 Financial Results and Provides Financial Expectations for 2025
Rhea-AI Summary
Neurocrine Biosciences (NBIX) reported strong financial results for Q4 and full-year 2024, with INGREZZA net product sales reaching $615M in Q4 and $2.3B for the full year, showing 23% and 26% year-over-year growth respectively. The company received FDA approval for CRENESSITY, a first-in-class treatment for congenital adrenal hyperplasia.
Q4 2024 financial highlights include total revenues of $627.7M, GAAP net income of $103.1M ($1.00 per share), and non-GAAP net income of $173.4M ($1.69 per share). The company ended 2024 with $1.8B in cash and equivalents.
For 2025, NBIX provided guidance for INGREZZA net product sales between $2.5B-$2.6B. The company plans to initiate Phase 3 programs for osavampator in major depressive disorder and NBI-568 in schizophrenia in H1 2025.
Positive
- INGREZZA sales grew 23% YoY to $615M in Q4 2024
- Full-year INGREZZA revenue increased 26% to $2.3B
- FDA approval and launch of CRENESSITY for congenital adrenal hyperplasia
- Strong cash position of $1.8B as of December 31, 2024
- Completed $300M share repurchase program
- Positive 2025 guidance with INGREZZA sales projected at $2.5-2.6B
Negative
- Q4 2024 GAAP net income decreased to $103.1M from $147.7M in Q4 2023
- Increased R&D expenses by 35% YoY to $185.6M in Q4 2024
- SG&A expenses rose 31.5% YoY to $287.8M in Q4 2024
News Market Reaction
On the day this news was published, NBIX declined 18.53%, reflecting a significant negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
INGREZZA® (valbenazine) Fourth Quarter and Full Year 2024 Net Product Sales of
INGREZZA® (valbenazine) Full Year 2025 Net Product Sales Guidance of
CRENESSITYTM (crinecerfont), a First-in-Class Treatment for Children and Adults with Classic Congenital Adrenal Hyperplasia, Approved and Launched in
Phase 3 Programs for Osavampator in Major Depressive Disorder and NBI-'568 in Schizophrenia Initiating in the First Half of 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
- INGREZZA fourth quarter and fiscal 2024 net product sales were
$615 million $2.3 billion - INGREZZA fourth quarter net product sales grew
23% compared to fourth quarter 2023, driven by strong underlying patient demand and improvement in gross-to-net dynamics - CRENESSITY fourth quarter and fiscal 2024 net product sales were
$2 million U.S. Food and Drug Administration (FDA) in December 2024
Other Key Financial Highlights
- Differences in fourth quarter 2024 GAAP and Non-GAAP operating expenses compared with fourth quarter 2023 were driven by:
- Increased R&D expense in support of an expanded and advancing portfolio including investments in osavampator in major depressive disorder, our muscarinic franchise and preclinical research and discovery activities.
- Increased SG&A expense includes incremental investment in CRENESSITY-related headcount, CRENESSITY-related pre-launch activities, and continued investment in INGREZZA, including the recent expansion of our psychiatry and long-term care sales teams in September 2024.
- Increased stock-based compensation expense (GAAP) of
$28 million
- Fourth quarter 2024 GAAP net income and earnings per share were
$103 million $1.00 $148 million $1.44 - Fourth quarter 2024 Non-GAAP net income and earnings per share were
$173 million $1.69 $158 million $1.54 - Differences in fourth quarter 2024 GAAP and Non-GAAP net income compared with fourth quarter 2023 driven by:
- Higher INGREZZA net sales
- Increased operating expenses to support expanding and advancing R&D portfolio, incremental investments for CRENESSITY pre-launch activities and INGREZZA recent sales force expansion
- Fourth quarter 2024 includes
$66 million $38 million - Fourth quarter 2024 includes a
$2 million $29 million
- As of December 31, 2024, repurchased and retired approximately 2.0 million shares of the Company's common stock valued at approximately
$240.5 million $300 million $300 million - At December 31, 2024, the Company had cash, cash equivalents and marketable securities totaling approximately
$1.8 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.
Recent Developments
- CRENESSITY was approved in December 2024 by the FDA as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia (CAH).
- Announced the initiation of the Phase 3 program for osavampator (formerly NBI-1065845 / TAK-653), a potential first-in-class AMPA positive allosteric modulator in development for patients with inadequate response to treatment of major depressive disorder (MDD).
- Announced amendment to strategic collaboration with Takeda to develop and commercialize osavampator. Under the amended agreement, Neurocrine will obtain exclusive rights for all indications to develop and commercialize osavampator in all territories worldwide except
Japan , where Takeda will acquire exclusive rights. Under the terms of the updated agreement, each company is responsible for development costs in their respective region, and both companies are eligible to receive royalty payments. - Received Centers for Medicare and Medicaid Services (CMS) notification in January that INGREZZA qualifies for the small biotech exemption under the Medicare Drug Price Negotiation Program.
- Announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-921355 in healthy adult participants. NBI-921355 is an investigational, selective inhibitor of voltage-gated sodium channels Nav1.2 and Nav1.6 and in development for the potential treatment of certain types of epilepsy.
- Presented subgroup analyses and data from the KINECT®-HD study showing the impact of INGREZZA capsules on emotional health and psychiatric stability in patients with chorea associated with Huntington's disease. The subgroup analysis showed consistent efficacy in reducing chorea compared to placebo across all identified subgroups, categorized by demographics and baseline assessment scores. A separate data analysis showed improvements in some aspects of emotional health with no worsening of psychiatric symptoms.
- Presented data from more than 300 patients diagnosed with tardive dyskinesia and treated with INGREZZA capsules. These data showed significant improvements in functional, social, emotional and health-related quality of life measures in Phase 3 and 4 studies and improvements in functional, social, independence, emotional and physical aspects of patients' lives and antipsychotic adherence in real-world practice.
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 |
3. | Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of |
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
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
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, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law.
TABLE 1
NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) | |||||||
Three Months Ended | Twelve Months Ended | ||||||
(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 | Twelve Months Ended | ||||||
(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 |
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 | Twelve Months Ended | ||||||
(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 | Twelve Months Ended | ||||||
(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 | Twelve Months Ended | ||||||
(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 | Twelve Months Ended | ||||||
(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 | |||
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SOURCE Neurocrine Biosciences, Inc.
FAQ
What was INGREZZA's revenue growth for Q4 2024 compared to Q4 2023?
What is Neurocrine's (NBIX) revenue guidance for INGREZZA in 2025?
How much cash does NBIX have as of December 31, 2024?
What was the impact of NBIX's share repurchase program in 2024?
When will NBIX initiate Phase 3 trials for osavampator and NBI-568?
