Neurocrine Biosciences Reports Third Quarter 2024 Financial Results and Raises 2024 INGREZZA Sales Guidance
INGREZZA® (valbenazine) Third Quarter Net Product Sales of $613 Million Representing 26% Year-Over-Year Growth
INGREZZA® (valbenazine) 2024 Net Product Sales Guidance Raised to $2.30 - $2.32 Billion
Board Authorizes $300 Million Share Repurchase Plan
SAN DIEGO, Oct. 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the third quarter ended September 30, 2024 and provided an update on its 2024 financial guidance.
"With continued INGREZZA growth across the tardive dyskinesia and Huntington's disease chorea indications, FDA Priority Review for crinecerfont in congenital adrenal hyperplasia, a deep neuroscience focused pipeline and a strong balance sheet, we are confident in our ability to help more patients than ever before," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences.
William Rastetter, Chairman of the Board of Directors of Neurocrine Biosciences, said, "The share repurchase authorization reflects the Board's confidence in Neurocrine's significant value creation potential. Importantly, the new share repurchase authorization preserves our flexibility to drive sustained growth through investments in INGREZZA and the anticipated launch of crinecerfont, while also advancing our diverse pipeline and maintaining our strong balance sheet."
Financial Highlights
Three Months Ended
September 30,
Nine Months Ended
September 30,
(unaudited, in millions, except per share data)
2024
2023
2024
2023
Revenues:
Net Product Sales
$ 616.6
$ 491.8
$ 1,709.4
$ 1,353.4
Collaboration Revenue
5.5
7.0
18.2
18.5
Total Revenues
$ 622.1
$ 498.8
$ 1,727.6
$ 1,371.9
GAAP Research and Development (R&D)
$ 195.0
$ 142.2
$ 545.5
$ 427.5
Non-GAAP R&D
$ 180.2
$ 125.0
$ 497.9
$ 372.7
GAAP Selling, General, and Administrative (SG&A)
$ 234.3
$ 204.2
$ 719.4
$ 668.7
Non-GAAP SG&A
$ 204.6
$ 169.7
$ 620.9
$ 563.4
GAAP Net Income
$ 129.8
$ 83.1
$ 238.2
$ 102.0
GAAP Earnings Per Share, Diluted
$ 1.24
$ 0.82
$ 2.29
$ 1.01
Non-GAAP Net Income
$ 189.2
$ 156.1
$ 482.9
$ 232.3
Non-GAAP Earnings Per Share, Diluted
$ 1.81
$ 1.54
$ 4.64
$ 2.31
(unaudited, in millions)
September 30,
2024
December 31,
2023
Total Cash, Cash Equivalents, and Marketable Securities
$ 1,871.9
$ 1,719.1
INGREZZA Net Product Sales Highlights
INGREZZA third quarter 2024 net product sales were $613 million and grew 26% compared to the third quarter 2023
Year-over-year growth driven by strong underlying patient demand and improvement in gross-to-net dynamics
Other Key Financial Highlights
Differences in third quarter 2024 GAAP and Non-GAAP operating expenses compared with third quarter 2023 were driven by:
Increased R&D expense in support of an expanded and advancing portfolio including investments in muscarinic compounds, gene therapy programs, and second generation VMAT2 inhibitors. Third quarter 2024 R&D expense includes $39 million for development milestones achieved under collaborations with Nxera Pharma UK Limited (Nxera, formerly known as Sosei Heptares) and Voyager Therapeutics, Inc. (Voyager).
Increased SG&A expense includes incremental investment in crinecerfont-related headcount, crinecerfont-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.
Third quarter 2024 GAAP net income and earnings per share were $130 million and $1.24, respectively, compared with $83 million and $0.82, respectively, for third quarter 2023
Third quarter 2024 Non-GAAP net income and earnings per share were $189 million and $1.81, respectively, compared with $156 million and $1.54, respectively, for third quarter 2023
Differences in third quarter 2024 GAAP and Non-GAAP net income compared with third quarter 2023 driven by:
Higher INGREZZA net sales and improved operating margin
Third quarter 2024 includes $17 million loss from changes in fair values of equity investments compared with $40 million loss for third quarter 2023 (Non-GAAP adjustment)
Third quarter 2024 includes $39 million of expense for development milestones achieved under collaborations with Nxera and Voyager
At September 30, 2024, the Company had cash, cash equivalents and marketable securities totaling approximately $1.9 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
Kyle W. Gano, Ph.D. appointed Chief Executive Officer effective October 11, 2024.
Announced the Company's Board of Directors has authorized a $300 million share repurchase plan. The Company subsequently intends to enter into a $300 million accelerated share repurchase transaction in the coming days, subject to market conditions, which will constitute the entirety of the authorized share repurchase plan.
Announced positive topline data for the Phase 2 study of NBI-1117568, a first-in-class, orally active, highly selective investigational M4 agonist, in development as a potential treatment for schizophrenia. The successful completion of the Phase 2 study triggered a $35 million milestone payment to Nxera in the third quarter of 2024. We expect to advance NBI-1117568 into Phase 3 development in the first half of 2025, which would trigger an additional $15 million milestone payment to Nxera upon initiation of the Phase 3 study.
Presented KINECT®-HD2 interim data at the 2024 MDS International Congress of Parkinson's Disease and Movement Disorders demonstrating robust and sustained improvements in chorea associated with Huntington's Disease through week 104 irrespective of antipsychotic use.
Announced the ERUDITE™ Phase 2 study of luvadaxistat (NBI-1065844) in cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint. In addition, we provided Takeda Pharmaceutical Company Limited with written notice of termination of the license agreement to develop and commercialize luvadaxistat and NBI-1065846. The termination is anticipated to be effective in April 2025.
Provided Idorsia Pharmaceuticals Ltd. with written notice of termination of the license agreement to develop and commercialize NBI-827104 in epileptic encephalopathy with continuous spike and wave during sleep. The termination is anticipated to be effective in January 2025.
Raised 2024 Net Sales Guidance and Updated Expense Guidance
Range
(in millions)
Low
High
INGREZZA Net Product Sales 1
$ 2,300
$ 2,320
GAAP R&D Expense 2
$ 700
$ 720
Non-GAAP R&D Expense 3
$ 635
$ 655
GAAP and Non-GAAP IPR&D 4
$ 10
$ 10
GAAP SG&A Expense 5
$ 970
$ 990
Non-GAAP SG&A Expense 3, 5
$ 825
$ 845
1.
INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease.
2.
GAAP R&D guidance includes $71 million of expense for development milestones achieved or deemed probable to achieve under collaborations (Nxera Pharma UK Limited, Takeda Pharmaceutical Company Limited, Voyager Therapeutics, Inc.) of which $39 million was recognized in the third quarter 2024. These milestone expenses are associated with our advancing pre-clinical and clinical pipeline.
3.
Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $65 million in R&D and $125 million in SG&A and vacated legacy campus facility costs, including office space impairment charges of approximately $20 million in SG&A. SG&A stock-based compensation includes an approximate $15 million charge to be recognized in the fourth quarter associated with the retirement of our CEO in October 2024.
4.
Acquired in-process R&D (IPR&D) is included in guidance once significant collaboration and licensing arrangements have been completed.
5.
SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth including the expansion of the psychiatry and long-term care sales teams in September and pre-launch commercial activities for crinecerfont.
Conference Call and Webcast Today at 8:00 AM Eastern TimeNeurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.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 8:00 a.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 BiosciencesNeurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's ...
