INGREZZA® (valbenazine) First Quarter Net
Product Sales of $506 Million
Representing 23% Year-Over-Year Growth
INGREZZA® SPRINKLE (valbenazine) Capsules
Approved by the U.S. FDA
Crinecerfont New Drug Applications for the Treatment of
Congenital Adrenal Hyperplasia Submitted to the U.S.
FDA
Positive Phase 2 Top-Line Data for NBI-1065845, a
Potential First-In-Class AMPA Positive Allosteric Modulator, in
Adults with Major Depressive Disorder
SAN
DIEGO, May 1, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced its financial
results for the first quarter ended March 31, 2024 and
provided an update on its 2024 financial guidance.
"Significant unmet need still exists for the many patients
living with tardive dyskinesia as exemplified with INGREZZA's first
quarter year-over-year growth of 23%," said Kevin Gorman, Ph.D., Chief Executive Officer of
Neurocrine Biosciences. "With the recent New Drug Application
submissions for crinecerfont, positive Phase 2 results for a
potential first-in-class medication in NBI-'845 for major
depressive disorder, and the deepest pipeline in our company's
history, Neurocrine Biosciences is well positioned to become a
leader in neuroscience."
Financial Highlights
|
Three Months
Ended
March
31,
|
(unaudited, in
millions, except per share data)
|
2024
|
|
2023
|
Revenues:
|
|
|
|
Net Product
Sales
|
$
509.0
|
|
$
415.3
|
Collaboration
Revenue
|
6.3
|
|
5.1
|
Total
Revenues
|
$
515.3
|
|
$
420.4
|
|
|
|
|
GAAP Research and
Development (R&D)
|
$
159.4
|
|
$
139.5
|
Non-GAAP
R&D
|
$
142.4
|
|
$
125.7
|
|
|
|
|
GAAP Selling, General
and Administrative (SG&A)
|
$
243.1
|
|
$
242.7
|
Non-GAAP
SG&A
|
$
215.6
|
|
$
216.6
|
|
|
|
|
GAAP Net Income
(Loss)
|
$
43.4
|
|
$
(76.6)
|
GAAP Earnings (Loss)
Per Share – Diluted
|
$
0.42
|
|
$
(0.79)
|
|
|
|
|
Non-GAAP Net Income
(Loss)
|
$
124.8
|
|
$
(49.5)
|
Non-GAAP Earnings
(Loss) Per Share – Diluted
|
$
1.20
|
|
$
(0.51)
|
|
|
|
|
(unaudited, in
millions)
|
March
31,
2024
|
|
December
31,
2023
|
Total Cash, Cash
Equivalents and Marketable Securities
|
$ 1,911.0
|
|
$ 1,719.1
|
INGREZZA Net Product Sales Highlights
- INGREZZA first quarter 2024 net product sales were $506 million and grew 23% compared to the first
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 first quarter 2024 GAAP and non-GAAP operating
expenses compared with first quarter 2023 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
- Flat SG&A expense includes continued investment in INGREZZA
and incremental investment in crinecerfont-related headcount and
pre-launch activities
- First quarter 2024 GAAP net income and earnings per share were
$43 million and $0.42, respectively, compared with GAAP net loss
and loss per share of $77 million and
$0.79, respectively, for first
quarter 2023
- First quarter 2024 non-GAAP net income and earnings per share
were $125 million and $1.20, respectively, compared with non-GAAP net
loss and loss per share of $50
million and $0.51,
respectively, for first quarter 2023
- Differences in first quarter 2024 GAAP and non-GAAP net income
compared with first quarter 2023 driven by:
- Higher INGREZZA net sales and improved operating
margin
- First quarter 2024 includes $89
million charge associated with convertible senior notes
election to settle outstanding principal and conversion premium in
cash (non-GAAP adjustment)
- First quarter 2023 includes Acquired In-Process R&D
(IPR&D) expense of $144 million
associated with expansion of strategic partnership with Voyager
Therapeutics, Inc. (Voyager)
- At March 31, 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
- In January, the Company elected to settle the convertible
senior notes due May 2024 in
cash.
- In April, the Company reported positive Phase 2 data for its
completed Phase 2 study of NBI-1065845 in adult subjects with major
depressive disorder. The study met its primary and key secondary
endpoints, demonstrating that once-daily, oral administration of
NBI-1065845 produced a statistically significant change from
baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total
score at both Day 28 (primary endpoint) and Day 56 (key secondary
endpoint).
- In April, the Company submitted two New Drug Applications to
the FDA for crinecerfont as a treatment for adult and pediatric
patients with classic congenital adrenal hyperplasia.
- In April, the Company received approval from the U.S. Food and
Drug Administration for INGREZZA SPRINKLE (valbenazine) capsules, a
new oral granules formulation of INGREZZA (valbenazine)
capsules.
Reaffirmed 2024 Net Sales Guidance and Updated Expense
Guidance
|
Range
|
(in
millions)
|
Low
|
|
High
|
INGREZZA Net Product
Sales 1
|
$
2,100
|
|
$
2,200
|
|
|
|
|
GAAP R&D Expense
2
|
$
665
|
|
$
695
|
Non-GAAP R&D
Expense 3
|
$
600
|
|
$
630
|
|
|
|
|
GAAP and Non-GAAP
IPR&D 4
|
$
6
|
|
$
6
|
|
|
|
|
GAAP SG&A Expense
5
|
$
920
|
|
$
940
|
Non-GAAP SG&A
Expense 3, 5
|
$
810
|
|
$
830
|
|
|
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 approximately $34 million expense for development
milestones in connection with our collaborations (Nxera, Voyager
and Takeda) achieved in first quarter 2024 or achievement is deemed
probable in second quarter 2024. These milestone expenses are
associated with our advancing pre-clinical and clinical
pipeline.
|
3.
|
Non-GAAP guidance
adjusted primarily to exclude estimated non-cash stock-based
compensation expense of $65 million in R&D and $110 million
in SG&A.
|
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 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
|
INGREZZA*
(Selective VMAT2
Inhibitor)
|
Sprinkle Formulation
for Tardive Dyskinesia
/ Chorea in Huntington's Disease
|
Approved by FDA on
April 30, 2024
|
Crinecerfont
(CRF1 Receptor Antagonist)
|
Congenital Adrenal
Hyperplasia
(Pediatric and
Adult)
|
Submitted New Drug
Applications to the FDA
|
NBI-1065845**
(AMPA
Potentiator)
|
Inadequate Response in
Major Depressive Disorder
|
Reported Positive
Top-Line Phase 2 Data;
Engaging with FDA on
Path Forward
|
Efmody
(Hydrocortisone
Modified Release Hard Capsules)
|
Adrenal
Insufficiency
|
Reported Positive
Top-Line Phase 2 Data
|
Efmody
(Hydrocortisone
Modified Release Hard Capsules)
|
Congenital Adrenal
Hyperplasia
|
Reported Positive
Top-Line Phase 2 Data
|
NBI-1117568†
(M4 Agonist)
|
Schizophrenia
|
Top-Line Phase 2 Data
in Q3'24
|
Luvadaxistat**
(DAAO
Inhibitor)
|
Cognitive Impairment
Associated with Schizophrenia
|
Top-Line Phase 2 Data
in Q3'24
|
NBI-1070770**
(NMDA NR2B
NAM)
|
Major Depressive
Disorder
|
Initiated Phase 2
Study
|
NBI-1065890
(Selective VMAT2
Inhibitor)
|
CNS
Indications
|
Initiated Phase 1
Study
|
NBI-1117569†
(M4-Prefering
Agonist)
|
CNS
Indications
|
Initiated Phase 1
Study
|
NBI-1117570†
(M1/M4 Dual
Agonist)
|
CNS
Indications
|
Initiated Phase 1
Study
|
NBI-1117567†
(M1 Agonist)
|
CNS
Indications
|
Initiating Phase 1
Study
|
NBI-1076986
(M4
Antagonist)
|
Movement
Disorders
|
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 Nxera Pharma UK
Limited (formerly Sosei Heptares)
|
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 800-343-4136 (US) or
203-518-9814 (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 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 BIOSCIENCES, NEUROCRINE and YOU DESERVE BRAVE SCIENCE
are registered trademarks 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, charges associated with 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
March 31, 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 OPERATIONS
(unaudited)
|
|
|
Three Months
Ended
March 31,
|
(in millions,
except per share data)
|
2024
|
|
2023
|
Revenues:
|
|
|
|
Net product
sales
|
$
509.0
|
|
$
415.3
|
Collaboration
revenue
|
6.3
|
|
5.1
|
Total
revenues
|
515.3
|
|
420.4
|
Operating
expenses:
|
|
|
|
Cost of
revenues
|
7.5
|
|
8.5
|
Research and
development
|
159.4
|
|
139.5
|
Acquired in-process
research and development
|
6.0
|
|
143.9
|
Selling, general and
administrative
|
243.1
|
|
242.7
|
Total operating
expenses
|
416.0
|
|
534.6
|
Operating income
(loss)
|
99.3
|
|
(114.2)
|
Other (expense)
income:
|
|
|
|
Interest
expense
|
(1.1)
|
|
(1.1)
|
Unrealized gain on
equity security investments
|
1.6
|
|
2.2
|
Charges associated with
convertible senior notes
|
(88.7)
|
|
—
|
Investment income and
other, net
|
23.4
|
|
9.8
|
Total other (expense)
income, net
|
(64.8)
|
|
10.9
|
Income (loss) before
benefit from income taxes
|
34.5
|
|
(103.3)
|
Benefit from income
taxes
|
(8.9)
|
|
(26.7)
|
Net income
(loss)
|
$
43.4
|
|
$
(76.6)
|
|
|
|
|
Earnings (loss) per
share, basic
|
$
0.43
|
|
$
(0.79)
|
Earnings (loss) per
share, diluted
|
$
0.42
|
|
$
(0.79)
|
|
|
|
|
Weighted average common
shares outstanding, basic
|
99.8
|
|
97.1
|
Weighted average common
shares outstanding, diluted
|
103.6
|
|
97.1
|
TABLE
2
|
|
NEUROCRINE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(unaudited)
|
|
(in
millions)
|
March
31,
2024
|
|
December
31,
2023
|
Cash, cash equivalents
and marketable securities
|
$
1,210.6
|
|
$
1,031.6
|
Other current
assets
|
588.4
|
|
575.4
|
Total current
assets
|
1,799.0
|
|
1,607.0
|
Deferred tax
assets
|
378.2
|
|
362.6
|
Debt securities
available-for-sale
|
700.4
|
|
687.5
|
Right-of-use
assets
|
270.8
|
|
276.5
|
Equity security
investments
|
163.5
|
|
161.9
|
Property and equipment,
net
|
75.3
|
|
70.8
|
Intangible assets,
net
|
34.3
|
|
35.5
|
Other assets
|
50.9
|
|
49.6
|
Total assets
|
$
3,472.4
|
|
$
3,251.4
|
|
|
|
|
Convertible senior
notes, at carrying value ($170.4 million face value)
|
$
122.8
|
|
$
170.1
|
Convertible senior
notes embedded derivative liability
|
136.2
|
|
—
|
Other current
liabilities
|
453.9
|
|
484.7
|
Total current
liabilities
|
712.9
|
|
654.8
|
Operating lease
liabilities
|
252.9
|
|
258.3
|
Other long-term
liabilities
|
120.5
|
|
106.3
|
Stockholders'
equity
|
2,386.1
|
|
2,232.0
|
Total liabilities and
stockholders' equity
|
$
3,472.4
|
|
$
3,251.4
|
TABLE
3
|
|
NEUROCRINE
BIOSCIENCES, INC.
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL RESULTS
(unaudited)
|
|
|
Three Months
Ended
March 31,
|
(in millions,
except per share data)
|
2024
|
|
2023
|
GAAP net income
(loss)
|
$
43.4
|
|
$
(76.6)
|
Adjustments:
|
|
|
|
Stock-based
compensation expense - R&D
|
17.0
|
|
13.8
|
Stock-based
compensation expense - SG&A
|
27.5
|
|
26.1
|
Charges associated with
convertible senior notes 1
|
88.7
|
|
—
|
Non-cash interest
related to convertible senior notes
|
0.2
|
|
0.2
|
Non-cash amortization
related to acquired intangible assets
|
0.9
|
|
0.9
|
Changes in fair value
of equity security investments 2
|
(1.6)
|
|
(2.2)
|
Income tax effect
related to reconciling items 3
|
(51.3)
|
|
(11.7)
|
Non-GAAP net
income
|
$
124.8
|
|
$
(49.5)
|
|
|
|
|
Diluted earnings per
share:
|
|
|
|
GAAP
|
$
0.42
|
|
$
(0.79)
|
Non-GAAP
|
$
1.20
|
|
$
(0.51)
|
|
|
1.
|
Reflects charges
associated with election to cash settle principal and conversion
premium of convertible senior notes and the requirement to
bifurcate the embedded conversion option and accrete to other
expense.
|
2.
|
Reflects periodic
fluctuations in the fair values of the Company's equity security
investments.
|
3.
|
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
March 31,
|
(in
millions)
|
2024
|
|
2023
|
GAAP cost of
revenues
|
$
7.5
|
|
$
8.5
|
Adjustments:
|
|
|
|
Non-cash amortization
related to acquired intangible assets
|
0.9
|
|
0.9
|
Non-GAAP cost of
revenues
|
$
6.6
|
|
$
7.6
|
|
|
|
|
|
Three Months
Ended
March 31,
|
(in
millions)
|
2024
|
|
2023
|
GAAP R&D
|
$
159.4
|
|
$
139.5
|
Adjustments:
|
|
|
|
Stock-based
compensation expense
|
17.0
|
|
13.8
|
Non-GAAP
R&D
|
$
142.4
|
|
$
125.7
|
|
|
|
|
|
Three Months
Ended
March 31,
|
(in
millions)
|
2024
|
|
2023
|
GAAP
SG&A
|
$
243.1
|
|
$
242.7
|
Adjustments:
|
|
|
|
Stock-based
compensation expense
|
27.5
|
|
26.1
|
Non-GAAP
SG&A
|
$
215.6
|
|
$
216.6
|
|
|
|
|
|
Three Months
Ended
March 31,
|
(in
millions)
|
2024
|
|
2023
|
GAAP other (expense)
income, net
|
$
(64.8)
|
|
$
10.9
|
Adjustments:
|
|
|
|
Charges associated with
convertible senior notes
|
88.7
|
|
—
|
Non-cash interest
related to convertible senior notes
|
0.2
|
|
0.2
|
Changes in fair value
of equity security investments
|
(1.6)
|
|
(2.2)
|
Non-GAAP other income,
net
|
$
22.5
|
|
$
8.9
|
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SOURCE Neurocrine Biosciences, Inc.