INGREZZA® (valbenazine) Second Quarter Net
Product Sales of $440 Million
Representing 26% Year-Over-Year Growth
INGREZZA® (valbenazine) 2023 Net Product Sales
Guidance Raised to $1.77 -
$1.82 Billion
SAN DIEGO, Aug. 1, 2023 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced its financial
results for the second quarter ended June 30, 2023 and raised
net sales guidance for INGREZZA in 2023.
"INGREZZA's performance reflects the significant benefit the
medicine is providing to patients with tardive dyskinesia enabling
us to raise guidance once again," said Kevin Gorman, Ph.D., Chief Executive Officer of
Neurocrine Biosciences. "Operationally, we are set up well in the
second half of 2023 with growing INGREZZA sales, a PDUFA for
valbenazine to treat chorea associated with Huntington's disease,
and meaningful progress with our muscarinic programs. Importantly,
we remain on-track for four pipeline read-outs in the fourth
quarter, including the Phase 3 studies of crinecerfont for the
treatment of pediatric and adult congenital adrenal
hyperplasia."
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
(unaudited, in
millions, except per share data)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
Net Product
Sales
|
$
446.3
|
|
$
352.0
|
|
$
861.6
|
|
$
657.0
|
Collaboration
Revenue
|
6.4
|
|
26.2
|
|
11.5
|
|
31.8
|
Total
Revenues
|
$
452.7
|
|
$
378.2
|
|
$
873.1
|
|
$
688.8
|
|
|
|
|
|
|
|
|
GAAP Research and
Development (R&D)
|
$
145.8
|
|
$
135.9
|
|
$
285.3
|
|
$
238.1
|
Non-GAAP
R&D
|
$
122.0
|
|
$
119.7
|
|
$
247.7
|
|
$
209.4
|
|
|
|
|
|
|
|
|
GAAP Selling, General
and Administrative (SG&A)
|
$
221.8
|
|
$
182.8
|
|
$
464.5
|
|
$
383.5
|
Non-GAAP
SG&A
|
$
177.1
|
|
$
149.5
|
|
$
393.7
|
|
$
325.7
|
|
|
|
|
|
|
|
|
GAAP Net Income
(Loss)
|
$
95.5
|
|
$
(16.9)
|
|
$
18.9
|
|
$
(3.0)
|
GAAP Earnings (Loss)
Per Share – Diluted
|
$
0.95
|
|
$
(0.18)
|
|
$
0.19
|
|
$
(0.03)
|
|
|
|
|
|
|
|
|
Non-GAAP Net
Income
|
$
125.7
|
|
$
82.1
|
|
$
76.2
|
|
$
111.8
|
Non-GAAP Earnings Per
Share – Diluted
|
$
1.25
|
|
$
0.84
|
|
$
0.76
|
|
$
1.14
|
|
|
|
|
|
|
|
|
(unaudited, in
millions)
|
|
|
|
|
June
30,
2023
|
|
December
31,
2022
|
Total Cash, Cash
Equivalents and Marketable Securities
|
$ 1,319.3
|
|
$ 1,288.7
|
Second Quarter INGREZZA Net Product Sales
Highlights:
- INGREZZA second quarter 2023 net product sales were
$440 million and grew 26% vs. the
second quarter 2022 driven by prescription demand
- Record number of new patients received therapy during the
second quarter of 2023
Second Quarter Financial Highlights:
- Second quarter 2023 GAAP net income and earnings per share of
$96 million and $0.95, respectively, compared with second quarter
2022 GAAP net loss and loss per share of $17
million and $0.18,
respectively, primarily driven by $70
million loss on extinguishment of debt in the second quarter
of 2022
- Second quarter 2023 non-GAAP net income and earnings per share
of $126 million and $1.25, respectively, compared with second quarter
2022 non-GAAP net income and earnings per share of $82 million and $0.84, respectively
- Differences in second quarter 2023 GAAP and non-GAAP operating
expenses compared with second quarter 2022 driven by:
-
- Increased R&D expense in support of an expanded and
advancing clinical portfolio
- Increased SG&A expense primarily due to ongoing
commercial initiatives
- At June 30, 2023, the Company had
cash, cash equivalents and marketable securities of approximately
$1.3 billion
A reconciliation of GAAP to non-GAAP financial results can be
found in Table 3 and Table 4 at the end of this earnings
release.
Updated 2023 INGREZZA Sales Guidance and Reaffirmed Operating
Expense Guidance:
|
Range
|
(in
millions)
|
Low
|
|
High
|
INGREZZA Net Product
Sales 1
|
$
1,770
|
|
$
1,820
|
|
|
|
|
GAAP R&D Expense
2
|
$
550
|
|
$
580
|
Non-GAAP R&D
Expense 3
|
$
495
|
|
$
525
|
|
|
|
|
GAAP and Non-GAAP
IPR&D 4
|
$
144
|
|
$
144
|
|
|
|
|
GAAP SG&A
Expense
|
$
850
|
|
$
870
|
Non-GAAP SG&A
Expense 3
|
$
730
|
|
$
750
|
|
1.
INGREZZA sales guidance for fiscal
2023 reflects expected sales of INGREZZA in tardive
dyskinesia only.
|
2. GAAP R&D
guidance includes amounts for milestones that are probable of
achievement or have been
achieved.
|
3. Non-GAAP guidance
adjusted to exclude estimated non-cash stock-based compensation
expense of
$65 million in R&D and $135 million
in SG&A.
|
4.
IPR&D guidance reflects acquired
in-process research and development once significant
collaboration and licensing arrangements have been
completed. IPR&D guidance
includes $143.9
million associated with the new strategic collaboration with
Voyager.
|
2023 Expected
Pipeline Milestones and Key Activities
|
Program
|
Indication
|
2023
Milestones / Key Activities
|
Valbenazine*
(Selective VMAT2
Inhibitor)
|
Chorea in Huntington's
Disease
|
PDUFA Date = August 20,
2023
|
Crinecerfont
(CRF1 Receptor
Antagonist)
|
Congenital Adrenal
Hyperplasia (Adult)
|
Top-Line Registrational
Data in Early Q4 2023
|
Congenital Adrenal
Hyperplasia (Pediatric)
|
Top-Line Registrational
Data in Early Q4 2023
|
NBI-921352**
(Selective
NaV1.6 Channel Blocker)
|
Focal Onset Seizure in
Adults
|
Top-Line Phase 2 Data
in Q4 2023
|
NBI-1065846†
(GPR-139
Agonist)
|
Anhedonia in Major
Depressive Disorder
|
Top-Line Phase 2 Data
in Q4 2023
|
NBI-1117570‡
(Dual M1/ M4
Agonist)
|
Treatment of
Schizophrenia
|
Clinical Trial
Application Accepted; Initiating Phase 1 Study in Q3
|
New Chemical Entity or
Entities
|
Indication(s)
TBD
|
Initiate at Least One
Phase 1 Study
|
|
Key: VMAT2 =
Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing
Factor Type 1; NaV1.6 = Sodium
Channel, Voltage-Gated; M1 / M4 = M1 / M4 Muscarinic Receptor; GPR
= Orphan G Protein Coupled Receptor
|
|
Neurocrine
Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has
commercialization rights in East Asia; **
In-Licensed from Xenon Pharmaceuticals; † Partnered with Takeda
Pharmaceutical Company Limited; ‡ In-Licensed from
Sosei Group Corporation65
|
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 800-895-3361 (US) or
785-424-1062 (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, Parkinson'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, Twitter
and Facebook. (*in collaboration with AbbVie)
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-related transaction 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 U.S. federal or state
legislative or regulatory and/or policy efforts which may result
in, among other things, an adverse impact on our revenues or
potential revenue; risks associated with 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 June 30, 2023.
Neurocrine Biosciences disclaims any obligation to update the
statements contained in this press release after the date
hereof.
TABLE
1
|
|
NEUROCRINE BIOSCIENCES, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(unaudited)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
(in millions,
except per share data)
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
446.3
|
|
$
352.0
|
|
$
861.6
|
|
$
657.0
|
|
Collaboration
revenue
|
|
6.4
|
|
26.2
|
|
11.5
|
|
31.8
|
Total
revenues
|
|
452.7
|
|
378.2
|
|
873.1
|
|
688.8
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
|
11.5
|
|
4.8
|
|
20.0
|
|
9.4
|
Research and
development
|
|
145.8
|
|
135.9
|
|
285.3
|
|
238.1
|
Acquired in-process
research and development
|
|
—
|
|
—
|
|
143.9
|
|
—
|
Selling, general and
administrative
|
|
221.8
|
|
182.8
|
|
464.5
|
|
383.5
|
Total operating
expenses
|
|
379.1
|
|
323.5
|
|
913.7
|
|
631.0
|
Operating income
(loss)
|
|
73.6
|
|
54.7
|
|
(40.6)
|
|
57.8
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(1.3)
|
|
(2.2)
|
|
(2.4)
|
|
(4.8)
|
Unrealized gain (loss)
on equity security investments
|
|
37.3
|
|
(7.4)
|
|
39.5
|
|
12.5
|
Loss on extinguishment
of convertible senior notes
|
|
—
|
|
(70.0)
|
|
—
|
|
(70.0)
|
Investment income and
other, net
|
|
12.0
|
|
1.6
|
|
21.8
|
|
2.6
|
Total other income
(expense), net
|
|
48.0
|
|
(78.0)
|
|
58.9
|
|
(59.7)
|
Income (loss) before
provision for (benefit from) income taxes
|
|
121.6
|
|
(23.3)
|
|
18.3
|
|
(1.9)
|
Provision for (benefit
from) income taxes
|
|
26.1
|
|
(6.4)
|
|
(0.6)
|
|
1.1
|
Net income
(loss)
|
|
$
95.5
|
|
$
(16.9)
|
|
$
18.9
|
|
$
(3.0)
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per
share, basic
|
|
$
0.98
|
|
$
(0.18)
|
|
$
0.19
|
|
$
(0.03)
|
Earnings (loss) per
share, diluted
|
|
$
0.95
|
|
$
(0.18)
|
|
$
0.19
|
|
$
(0.03)
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic
|
|
97.6
|
|
95.6
|
|
97.4
|
|
95.4
|
Weighted average common
shares outstanding, diluted
|
|
100.2
|
|
95.6
|
|
100.3
|
|
95.4
|
TABLE
2
|
|
NEUROCRINE BIOSCIENCES,
INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(unaudited)
|
|
(in
millions)
|
June
30,
2023
|
|
December
31,
2022
|
Cash, cash equivalents
and marketable securities
|
$
976.7
|
|
$
989.3
|
Other current
assets
|
519.9
|
|
464.2
|
Total current
assets
|
1,496.6
|
|
1,453.5
|
Deferred tax
assets
|
379.0
|
|
305.9
|
Debt securities
available-for-sale
|
342.6
|
|
299.4
|
Right-of-use
assets
|
83.5
|
|
87.0
|
Equity security
investments
|
173.0
|
|
102.1
|
Property and equipment,
net
|
65.6
|
|
58.6
|
Intangible assets,
net
|
36.9
|
|
37.2
|
Other assets
|
35.9
|
|
25.0
|
Total assets
|
$
2,613.1
|
|
$
2,368.7
|
|
|
|
|
Convertible senior
notes
|
$
169.7
|
|
$
169.4
|
Other current
liabilities
|
412.8
|
|
368.3
|
Total current
liabilities
|
582.5
|
|
537.7
|
Operating lease
liabilities
|
89.1
|
|
93.5
|
Other long-term
liabilities
|
88.5
|
|
29.7
|
Stockholders'
equity
|
1,853.0
|
|
1,707.8
|
Total liabilities and
stockholders' equity
|
$
2,613.1
|
|
$
2,368.7
|
TABLE
3
|
|
NEUROCRINE BIOSCIENCES, INC.
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL RESULTS
|
(unaudited)
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
(in millions,
except per share data)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP net income
(loss)
|
$
95.5
|
|
$
(16.9)
|
|
$
18.9
|
|
$
(3.0)
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based
compensation expense - R&D
|
23.8
|
|
16.2
|
|
37.6
|
|
28.7
|
Stock-based
compensation expense - SG&A
|
44.7
|
|
33.3
|
|
70.8
|
|
57.8
|
Loss on extinguishment
of convertible senior notes 1
|
—
|
|
70.0
|
|
—
|
|
70.0
|
Non-cash interest
related to convertible senior notes
|
0.2
|
|
0.4
|
|
0.4
|
|
0.8
|
Non-cash amortization
related to acquired intangible assets
|
0.9
|
|
—
|
|
1.8
|
|
—
|
Changes in fair value
of equity security investments 2
|
(37.3)
|
|
7.4
|
|
(39.5)
|
|
(12.5)
|
Income tax effect
related to reconciling items 3
|
(2.1)
|
|
(28.3)
|
|
(13.8)
|
|
(30.0)
|
Non-GAAP net
income
|
$
125.7
|
|
$
82.1
|
|
$
76.2
|
|
$
111.8
|
|
|
|
|
|
|
|
|
Diluted earnings (loss)
per share:
|
|
|
|
|
|
|
|
GAAP
|
$
0.95
|
|
$
(0.18)
|
|
$
0.19
|
|
$
(0.03)
|
Non-GAAP
4
|
$
1.25
|
|
$
0.84
|
|
$
0.76
|
|
$
1.14
|
|
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 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 non-cash stock-
based compensation.
|
4. Non-GAAP diluted
earnings per share for the three and six months ended June 30,
2022, reflect diluted shares of 98.2
million and 97.9 million, respectively, which were calculated in
accordance with the guidance on earnings per share
in ASC 260.
|
TABLE
4
|
|
NEUROCRINE BIOSCIENCES, INC.
|
RECONCILIATION OF
GAAP TO NON-GAAP EXPENSES
|
(unaudited)
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
(in
millions)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP cost of
revenues
|
$
11.5
|
|
$
4.8
|
|
$
20.0
|
|
$
9.4
|
Adjustments:
|
|
|
|
|
|
|
|
Non-cash amortization
related to acquired intangible assets
|
0.9
|
|
—
|
|
1.8
|
|
—
|
Non-GAAP cost of
revenues
|
$
10.6
|
|
$
4.8
|
|
$
18.2
|
|
$
9.4
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
(in
millions)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP R&D
|
$
145.8
|
|
$
135.9
|
|
$
285.3
|
|
$
238.1
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
23.8
|
|
16.2
|
|
37.6
|
|
28.7
|
Non-GAAP
R&D
|
$
122.0
|
|
$
119.7
|
|
$
247.7
|
|
$
209.4
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
(in
millions)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP
SG&A
|
$
221.8
|
|
$
182.8
|
|
$
464.5
|
|
$
383.5
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
44.7
|
|
33.3
|
|
70.8
|
|
57.8
|
Non-GAAP
SG&A
|
$
177.1
|
|
$
149.5
|
|
$
393.7
|
|
$
325.7
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
(in
millions)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP other income,
net
|
$
48.0
|
|
$
(78.0)
|
|
$
58.9
|
|
$
(59.7)
|
Adjustments:
|
|
|
|
|
|
|
|
Loss on extinguishment
of convertible senior notes
|
—
|
|
70.0
|
|
—
|
|
70.0
|
Non-cash interest
related to convertible senior notes
|
0.2
|
|
0.4
|
|
0.4
|
|
0.8
|
Changes in fair value
of equity security investments
|
(37.3)
|
|
7.4
|
|
(39.5)
|
|
(12.5)
|
Non-GAAP other income
(expense), net
|
$
10.9
|
|
$
(0.2)
|
|
$
19.8
|
|
$
(1.4)
|
|
|
|
|
|
|
|
|
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SOURCE Neurocrine Biosciences, Inc.