INGREZZA® (valbenazine) Fourth Quarter and Full
Year 2023 Net Product Sales of $500
Million and $1.84 Billion,
Representing Year-over-Year Growth of 25% and 29%
Respectively
INGREZZA® (valbenazine) Full Year 2024 Net
Product Sales Guidance of $2.1 -
$2.2 Billion
Crinecerfont FDA Regulatory Submission Anticipated in the
Second Quarter for the Treatment of Congenital Adrenal Hyperplasia
in Adults and Pediatrics
SAN
DIEGO, Feb. 7, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced its financial
results for the fourth quarter and full year ended
December 31, 2023 and provided financial guidance for
2024.
"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.
About Neurocrine Biosciences
Neurocrine 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 diverse portfolio includes FDA-approved treatments for
tardive dyskinesia, chorea associated with Huntington's disease,
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 is a registered trademark of Neurocrine Biosciences,
Inc. The Neurocrine logo 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, loss on extinguishment of convertible senior
notes, non-cash interest expense related to convertible debt,
non-cash amortization expense related to acquired intangible
assets, acquisition and integration costs, changes in fair value of
equity security 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.
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; 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. Among the
factors that could cause actual results to differ materially from
those indicated in the forward-looking statements are: our future
financial and operating performance; risks and uncertainties
associated with the commercialization of INGREZZA; 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
clinical 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 SEC,
including our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023. 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 OPERATIONS
(unaudited)
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
(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
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
revenues
|
8.5
|
|
7.7
|
|
39.7
|
|
23.2
|
Research and
development
|
137.5
|
|
118.0
|
|
565.0
|
|
463.8
|
Acquired in-process
research and development
|
—
|
|
—
|
|
143.9
|
|
—
|
Selling, general and
administrative
|
218.9
|
|
182.9
|
|
887.6
|
|
752.7
|
Total operating
expenses
|
364.9
|
|
308.6
|
|
1,636.2
|
|
1,239.7
|
Operating
income
|
150.3
|
|
103.4
|
|
250.9
|
|
249.0
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(1.1)
|
|
(1.1)
|
|
(4.6)
|
|
(7.1)
|
Unrealized gain on
equity security investments
|
29.0
|
|
7.2
|
|
28.4
|
|
30.8
|
Loss on extinguishment
of convertible senior notes
|
—
|
|
—
|
|
—
|
|
(70.0)
|
Investment income and
other, net
|
20.0
|
|
8.4
|
|
57.4
|
|
11.2
|
Total other income
(expense), net
|
47.9
|
|
14.5
|
|
81.2
|
|
(35.1)
|
Income before provision
for income taxes
|
198.2
|
|
117.9
|
|
332.1
|
|
213.9
|
Provision for income
taxes
|
50.5
|
|
28.9
|
|
82.4
|
|
59.4
|
Net income
|
$
147.7
|
|
$
89.0
|
|
$
249.7
|
|
$
154.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share,
basic
|
$
1.50
|
|
$
0.92
|
|
$
2.56
|
|
$
1.61
|
Earnings per share,
diluted
|
$
1.44
|
|
$
0.88
|
|
$
2.47
|
|
$
1.56
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic
|
98.4
|
|
96.3
|
|
97.7
|
|
95.8
|
Weighted average common
shares outstanding, diluted
|
102.3
|
|
100.8
|
|
101.0
|
|
98.9
|
TABLE
2
NEUROCRINE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(unaudited)
|
|
(in
millions)
|
December
31,
2023
|
|
December
31,
2022
|
Cash, cash equivalents
and marketable securities
|
$
1,031.6
|
|
$
989.3
|
Other current
assets
|
575.4
|
|
464.2
|
Total current
assets
|
1,607.0
|
|
1,453.5
|
Deferred tax
assets
|
362.6
|
|
305.9
|
Debt securities
available-for-sale
|
687.5
|
|
299.4
|
Right-of-use
assets
|
276.5
|
|
87.0
|
Equity security
investments
|
161.9
|
|
102.1
|
Property and equipment,
net
|
70.8
|
|
58.6
|
Intangible assets,
net
|
35.5
|
|
37.2
|
Other assets
|
49.6
|
|
25.0
|
Total assets
|
$
3,251.4
|
|
$
2,368.7
|
|
|
|
|
|
|
|
|
Convertible senior
notes
|
$
170.1
|
|
$
169.4
|
Other current
liabilities
|
484.7
|
|
368.3
|
Total current
liabilities
|
654.8
|
|
537.7
|
Operating lease
liabilities
|
258.3
|
|
93.5
|
Other long-term
liabilities
|
106.3
|
|
29.7
|
Stockholders'
equity
|
2,232.0
|
|
1,707.8
|
Total liabilities and
stockholders' equity
|
$
3,251.4
|
|
$
2,368.7
|
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)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP net
income
|
$
147.7
|
|
$
89.0
|
|
$
249.7
|
|
$
154.5
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based
compensation expense - R&D
|
13.2
|
|
14.1
|
|
68.0
|
|
57.7
|
Stock-based
compensation expense - SG&A
|
24.9
|
|
29.4
|
|
126.3
|
|
115.4
|
Loss on extinguishment
of convertible senior notes 1
|
—
|
|
—
|
|
—
|
|
70.0
|
Non-cash interest
related to convertible senior notes
|
0.1
|
|
0.2
|
|
0.7
|
|
1.2
|
Non-cash amortization
related to acquired intangible assets
|
0.8
|
|
0.5
|
|
3.5
|
|
0.5
|
Acquisition and
integration costs - SG&A 2
|
—
|
|
1.7
|
|
3.9
|
|
1.7
|
Changes in fair value
of equity security investments 3
|
(29.0)
|
|
(7.2)
|
|
(28.4)
|
|
(30.8)
|
Changes in foreign
currency exchange rates
|
—
|
|
(1.5)
|
|
—
|
|
1.9
|
Income tax effect
related to reconciling items 4
|
—
|
|
(1.5)
|
|
(33.7)
|
|
(28.9)
|
Non-GAAP net
income
|
$
157.7
|
|
$
124.7
|
|
$
390.0
|
|
$
343.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per
share:
|
|
|
|
|
|
|
|
GAAP
|
$
1.44
|
|
$
0.88
|
|
$
2.47
|
|
$
1.56
|
Non-GAAP
|
$
1.54
|
|
$
1.24
|
|
$
3.86
|
|
$
3.47
|
|
|
1.
|
The Company recognized
a loss on extinguishment of $70.0 million related to the partial
repurchase of its convertible senior notes in the second quarter of
2022.
|
2.
|
Reflects transaction
and integration costs for contract terminations related to the
Diurnal Group plc acquisition.
|
3.
|
Reflects periodic
fluctuations in the fair values of the Company's equity security
investments.
|
4.
|
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 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)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP cost of
revenues
|
$
8.5
|
|
$
7.7
|
|
$
39.7
|
|
$
23.2
|
Adjustments:
|
|
|
|
|
|
|
|
Non-cash amortization
related to acquired intangible assets
|
0.8
|
|
0.5
|
|
3.5
|
|
0.5
|
Non-GAAP cost of
revenues
|
$
7.7
|
|
$
7.2
|
|
$
36.2
|
|
$
22.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
(in
millions)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP R&D
|
$
137.5
|
|
$
118.0
|
|
$
565.0
|
|
$
463.8
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
13.2
|
|
14.1
|
|
68.0
|
|
57.7
|
Non-GAAP
R&D
|
$
124.3
|
|
$
103.9
|
|
$
497.0
|
|
$
406.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
(in
millions)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP
SG&A
|
$
218.9
|
|
$
182.9
|
|
$
887.6
|
|
$
752.7
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
24.9
|
|
29.4
|
|
126.3
|
|
115.4
|
Acquisition and
integration costs
|
—
|
|
1.7
|
|
3.9
|
|
1.7
|
Non-GAAP
SG&A
|
$
194.0
|
|
$
151.8
|
|
$
757.4
|
|
$
635.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
(in
millions)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP other income
(expense), net
|
$
47.9
|
|
$
14.5
|
|
$
81.2
|
|
$
(35.1)
|
Adjustments:
|
|
|
|
|
|
|
|
Loss on extinguishment
of convertible senior notes
|
—
|
|
—
|
|
—
|
|
70.0
|
Non-cash interest
related to convertible senior notes
|
0.1
|
|
0.2
|
|
0.7
|
|
1.2
|
Changes in fair value
of equity security investments
|
(29.0)
|
|
(7.2)
|
|
(28.4)
|
|
(30.8)
|
Changes in foreign
currency exchange rates
|
—
|
|
(1.5)
|
|
—
|
|
1.9
|
Non-GAAP other income,
net
|
$
19.0
|
|
$
6.0
|
|
$
53.5
|
|
$
7.2
|
|
|
|
|
|
|
|
|
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SOURCE Neurocrine Biosciences, Inc.