On February 6, 2025 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the fourth quarter and full year ended December 31, 2024 and provided financial guidance for 2025 (Press release, Neurocrine Biosciences, FEB 6, 2025, View Source [SID1234650085]).
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"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 and $2.3 billion, respectively
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 reflecting initial pharmacy orders following approval by the 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 primarily related to performance-based awards achievement associated with CRENESSITY FDA approval and a charge associated with the retirement of our CEO in October 2024.
Fourth quarter 2024 GAAP net income and earnings per share were $103 million and $1.00, respectively, compared with $148 million and $1.44, respectively, for fourth quarter 2023
Fourth quarter 2024 Non-GAAP net income and earnings per share were $173 million and $1.69, respectively, compared with $158 million and $1.54, respectively, for fourth quarter 2023
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 of stock-based compensation expense compared with $38 million for fourth quarter 2023 (Non-GAAP adjustment)
Fourth quarter 2024 includes a $2 million loss from changes in fair values of equity investments compared with a $29 million gain for fourth quarter 2023 (Non-GAAP adjustment)
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 pursuant to a previously announced $300 million accelerated share repurchase (ASR) program. The $300 million program was completed in early February 2025 repurchasing and retiring approximately 2.3 million shares.
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 $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.