On February 7, 2024 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided financial guidance for 2024 (Press release, Neurocrine Biosciences, FEB 7, 2024, View Source [SID1234639913]).
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"I’m exceptionally proud of the progress we made with INGREZZA last year, helping more patients than ever before treat their tardive dyskinesia. In addition, the positive Phase 3 crinecerfont results for the treatment of congenital adrenal hyperplasia opens the door for us to help patients living with a disabling neuroendocrine disorder," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With a strong foundation in INGREZZA, a potential second important growth driver in crinecerfont, and an advancing pipeline, Neurocrine Biosciences is making significant progress towards becoming a leading neuroscience focused company."
Financial Highlights
Three Months Ended
December 31,
Twelve Months Ended
December 31,
(unaudited, in millions, except per share data)
2023
2022
2023
2022
Revenues:
Net Product Sales
$ 507.2
$ 404.6
$ 1,860.6
$ 1,440.9
Collaboration Revenue
8.0
7.4
26.5
47.8
Total Revenues
$ 515.2
$ 412.0
$ 1,887.1
$ 1,488.7
GAAP Research and Development (R&D)
$ 137.5
$ 118.0
$ 565.0
$ 463.8
Non-GAAP R&D
$ 124.3
$ 103.9
$ 497.0
$ 406.1
GAAP Selling, General and Administrative (SG&A)
$ 218.9
$ 182.9
$ 887.6
$ 752.7
Non-GAAP SG&A
$ 194.0
$ 151.8
$ 757.4
$ 635.6
GAAP Net Income
$ 147.7
$ 89.0
$ 249.7
$ 154.5
GAAP Earnings Per Share – Diluted
$ 1.44
$ 0.88
$ 2.47
$ 1.56
Non-GAAP Net Income
$ 157.7
$ 124.7
$ 390.0
$ 343.2
Non-GAAP Earnings Per Share – Diluted
$ 1.54
$ 1.24
$ 3.86
$ 3.47
(unaudited, in millions)
December 31,
2023
December 31,
2022
Total Cash, Cash Equivalents and Marketable Securities
$ 1,719.1
$ 1,288.7
INGREZZA Net Product Sales Highlights
INGREZZA fourth quarter and fiscal 2023 net product sales were $500 million and $1.84 billion, respectively
INGREZZA fourth quarter net product sales grew 25% compared with fourth quarter 2022, driven by strong underlying patient demand offset slightly by seasonal gross-to-net dynamics
Other Key Financial Highlights
Differences in fourth quarter 2023 GAAP and non-GAAP operating expenses compared with fourth quarter 2022 were driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio including preclinical investments in muscarinic compounds, gene therapy programs and second generation VMAT2 inhibitors
Increased SG&A expense primarily due to ongoing commercial initiatives supporting INGREZZA growth including the expanded indication to treat chorea associated with Huntington’s disease
Fourth quarter 2023 GAAP net income and earnings per share were $148 million and $1.44, respectively, compared with $89 million and $0.88, respectively, for fourth quarter 2022
Fourth quarter 2023 non-GAAP net income and earnings per share were $158 million and $1.54, respectively, compared with $125 million and $1.24, respectively, for fourth quarter 2022
At December 31, 2023, the Company had cash, cash equivalents and marketable securities totaling approximately $1.7 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
In November 2023, the Company announced that all patent litigation brought by Neurocrine Biosciences against the companies that filed Abbreviated New Drug Applications (ANDA) to the FDA seeking approval to market generic versions of INGREZZA prior to the expiration of the Orange Book listed patents have been resolved. Accordingly, such companies have the right to sell generic versions of INGREZZA in the U.S. beginning March 2038, or earlier under certain circumstances.
In December 2023, the Company announced crinecerfont received Breakthrough Therapy designation from the FDA for the treatment of Congenital Adrenal Hyperplasia in adults and pediatrics.
Full Year 2024 Financial Guidance
Range
(in millions)
Low
High
INGREZZA Net Product Sales 1
$ 2,100
$ 2,200
GAAP R&D Expense 2
$ 645
$ 675
Non-GAAP R&D Expense 3
$ 570
$ 600
GAAP SG&A Expense 4
$ 930
$ 950
Non-GAAP SG&A Expense 3, 4
$ 830
$ 850
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 expense for development milestones once determined achievement is deemed probable. 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 primarily to exclude estimated non-cash stock-based compensation expense of $75 million in R&D and $100 million in SG&A.
4.
SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth including the expanded indication to treat chorea associated with Huntington’s disease and pre-launch commercial activities for crinecerfont.
2024 Expected Pipeline Milestones and Key Activities
Program
Indication
Expected Milestones / Key Activities
Valbenazine*
(Selective VMAT2 Inhibitor)
Sprinkle Formulation for Tardive Dyskinesia
/ Chorea in Huntington’s Disease
PDUFA April 30, 2024
Crinecerfont
(CRF1 Receptor Antagonist)
Congenital Adrenal Hyperplasia
(Pediatric and Adult)
Submitting New Drug Application to the
FDA in Q2’24
Efmody
(Hydrocortisone Modified
Release Hard Capsules)
Adrenal Insufficiency
Top-Line Phase 2 Data in 1H’24
Efmody
(Hydrocortisone Modified
Release Hard Capsules)
Congenital Adrenal Hyperplasia
Top-Line Phase 2 Data in 1H’24
NBI-1065845**
(AMPA Potentiator)
Inadequate Response in Major Depressive
Disorder
Top-Line Phase 2 Data in 1H’24
NBI-1117568†
(M4 Agonist)
Schizophrenia
Top-Line Phase 2 Data in 2H’24
Luvadaxistat**
(DAAO Inhibitor)
Cognitive Impairment Associated with
Schizophrenia
Top-Line Phase 2 Data in 2H’24
NBI-1070770**
(NMDA NR2B NAM)
Major Depressive Disorder
Initiating Phase 2 Study
NBI-1117567†
(M1 Agonist)
CNS Indications
Initiating Phase 1 Study
NBI-1076986
(M4 Antagonist)
Movement Disorders
Initiating Phase 1 Study
NBI-1065890
(Selective VMAT2 Inhibitor)
CNS Indications
Initiating Phase 1 Study
Key: VMAT2 = Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing Factor Type 1; AMPA = alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid; M4 = M4 Muscarinic Receptor; DAAO = d-amino acid oxidase; NMDA NR2B NAM = n-methyl-d-aspartate Receptor Subtype 2B Negative Allosteric Modulator; M1 = M1 Muscarinic Receptor
Neurocrine Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia; ** Partnered with Takeda Pharmaceutical Company Limited; † In-Licensed from Sosei Group Corporation
Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine 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 can also be accessed 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.