- Fourth Quarter 2018 Net Sales Grew to $59.6
Million, a 37% Increase Over 4Q17
- Full Year 2018 Net Sales Grew to $223.8
Million, a 79% Increase Over Full Year 2017
- Late Stage Pipeline Progressing with Five
Clinical Programs Ongoing or Commencing in 2019
- 2019 Guidance: Net Sales $275 Million to $300
Million
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system (CNS) disorders, today announced its financial
results for the fourth quarter and full year ended December 31,
2018.
“Our team successfully executed on all three of our strategic
pillars in 2018. We grew NUPLAZID in Parkinson’s disease psychosis,
leveraged pimavanserin in additional large market CNS indications
with positive data from our Phase 2 CLARITY study in adjunctive
treatment of major depressive disorder, and expanded our CNS
pipeline with the acquisition of the North American rights for
trofinetide,” said Steve Davis, ACADIA’s Chief Executive Officer.
“2019 will be a pivotal year for ACADIA. We are on track to
announce top-line data from our Phase 3 pimavanserin study in
adjunctive treatment of schizophrenia mid-year. In addition, we
expect to realize strong NUPLAZID revenue and volume growth, while
advancing our late-stage pipeline.”
Recent Highlights
- Announced positive top-line results
from the Phase 2 CLARITY trial of pimavanserin for adjunctive
treatment in patients with major depressive disorder (MDD) in
October 2018.
- Conducted an End-of-Phase 2 meeting
with the FDA confirming the development plans for pimavanserin as a
potential adjunctive therapy for MDD in February 2019.
- The Company plans to initiate two Phase
3 trials for pimavanserin as an adjunctive treatment for MDD in the
first half of 2019.
- The Company has confirmed its Phase 3
study design for trofinetide in Rett syndrome with the FDA and
plans to initiate this trial in the second half of 2019.
- Completed a public offering with net
proceeds of approximately $298.5 million in November 2018.
- Appointed Serge Stankovic, M.D.,
M.S.P.H., as President in November 2018.
Financial Results
RevenueNet sales of NUPLAZID® (pimavanserin) were $59.6 million
for the fourth quarter of 2018, an increase of 37% as compared to
$43.6 million reported for the fourth quarter of 2017. For the year
ended December 31, 2018 and 2017, ACADIA reported net product sales
of $223.8 million and $124.9 million, respectively, an increase of
79%.
Research and DevelopmentResearch and development expenses for
the fourth quarter of 2018 were $48.2 million, compared to $43.2
million for the same period of 2017. For the year ended December
31, 2018 and 2017, research and development expenses were $187.2
million and $149.2 million, respectively. The increase in research
and development expenses during the 2018 periods as compared to
2017 was primarily due to additional clinical study costs incurred
by the Company as it continues to invest in additional pipeline
programs for pimavanserin as well as an upfront payment of $10.0
million to Neuren Pharmaceuticals for trofinetide in the third
quarter of 2018.
Selling, General and AdministrativeSelling, general and
administrative expenses for the fourth quarter of 2018 were $74.3
million, compared to $66.7 million for the same period of 2017. For
the year ended December 31, 2018 and 2017, selling, general and
administrative expenses were $265.8 million and $255.1 million,
respectively. The increase in selling, general and administrative
expenses during the 2018 periods as compared to 2017 was primarily
due to an increase in advertising expenses related to our
direct-to-consumer advertising campaign.
Net LossFor the fourth quarter of 2018, ACADIA reported a net
loss of $65.5 million, or $0.50 per common share, compared to a net
loss of $68.9 million, or $0.55 per common share, for the same
period in 2017. The net losses in the fourth quarter of 2018 and
2017 included $20.4 million and $22.0 million,
respectively, of non-cash stock-based compensation expense. For the
year ended December 31, 2018, ACADIA reported a net loss of $245.2
million, or $1.94 per common share, compared to a net loss of
$289.4 million, or $2.36 per common share, for the same period in
2017. The net losses for the year ended December 31, 2018 and 2017
included $81.6 million and $75.5 million, respectively, of non-cash
stock-based compensation expense.
Cash and InvestmentsAt December 31, 2018, ACADIA’s cash, cash
equivalents, and investment securities totaled $473.5 million,
compared to $341.3 million at December 31, 2017.
2019 Financial Guidance
- NUPLAZID net sales are expected to be
between $275 million and $300 million.
- GAAP R&D is expected to be between
$250 million and $265 million. The increase compared to 2018
reflects the planned progression of five late-stage clinical
programs in 2019.
- GAAP SG&A is expected to be between
$280 million and $295 million.
- Non-cash stock-based compensation
expense is expected to be between $80 million and $90 million.
Conference Call and Webcast InformationACADIA management will
review its fourth quarter and full year 2018 financial results and
operations via conference call and webcast today at 5:00 p.m.
Eastern Time. The conference call may be accessed by dialing
855-638-4820 for participants in the U.S. or Canada and
443-877-4067 for international callers (reference passcode
3094204). A telephone replay of the conference call may be accessed
through March 12, 2019 by dialing 855-859-2056 for callers in the
U.S. or Canada and 404-537-3406 for international callers
(reference passcode 3094204). The conference call also will be
webcast live on ACADIA’s website, www.acadia-pharm.com, under the
investors section and will be archived there through March 26,
2019.
About NUPLAZID® (pimavanserin)NUPLAZID is the first and
only FDA-approved treatment for hallucinations and delusions
associated with Parkinson’s disease psychosis. NUPLAZID is a
non-dopaminergic, selective serotonin inverse agonist (SSIA)
preferentially targeting 5-HT2A receptors that are thought to
play an important role in Parkinson’s disease psychosis. NUPLAZID
is an oral medicine taken once a day with a recommended dose of 34
mg. ACADIA discovered and developed this new chemical entity and
holds worldwide rights to develop and commercialize NUPLAZID.
About ACADIA PharmaceuticalsACADIA is a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system disorders. ACADIA has developed and is
commercializing the first and only medicine approved for the
treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. In addition, ACADIA has ongoing
clinical development efforts in additional areas with significant
unmet need, including dementia-related psychosis, schizophrenia
inadequate response, schizophrenia-negative symptoms, major
depressive disorder, and Rett syndrome. This press release and
further information about ACADIA can be found at:
www.acadia-pharm.com.
Forward-Looking StatementsStatements in this press release that
are not strictly historical in nature are forward-looking
statements. These statements include, but are not limited to,
statements related to: the potential opportunity for future growth
in sales of NUPLAZID, including through sales of new dosages and
forms; the timing of ongoing and future clinical studies for
pimavanserin; the development and commercialization of trofinetide;
and guidance for full-year 2019 NUPLAZID net sales and certain
expense line items. These statements are only predictions based on
current information and expectations and involve a number of risks
and uncertainties. Actual events or results may differ materially
from those projected in any of such statements due to various
factors, including the uncertainty of future commercial sales and
related items that would impact net sales during 2019, the risks
and uncertainties inherent in drug discovery, development, approval
and commercialization, and the fact that past results of clinical
trials may not be indicative of future trial results. For a
discussion of these and other factors, please refer to ACADIA’s
annual report on Form 10-K for the year ended December 31, 2017 as
well as ACADIA’s subsequent filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. This caution is made under the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof, except as required by law.
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended
December 31, Years Ended December 31, 2018
2017 2018
2017 Revenues Product sales, net $ 59,571 $ 43,562 $
223,807 $ 124,901 Total revenues 59,571 43,562 223,807 124,901
Operating expenses Cost of product sales, license fees and
royalties (1) 4,392 3,703 18,330 13,060 Research and development
(1) 48,183 43,179 187,163 149,189 Selling, general and
administrative (1) 74,271 66,689 265,758
255,062 Total operating expenses 126,846
113,571 471,251 417,311 Loss from operations (67,275
) (70,009 ) (247,444 ) (292,410 ) Interest income, net 1,670 1,107
5,348 4,126 Other expense 127 — (1,840 )
— Loss before income taxes (65,478 ) (68,902 ) (243,936 )
(288,284 ) Income tax expense 14 (31 ) 1,256
1,119 Net loss $ (65,492 ) $ (68,871 ) $ (245,192 ) $
(289,403 ) Net loss per common share, basic and diluted $ (0.50 ) $
(0.55 ) $ (1.94 ) $ (2.36 ) Weighted average common shares
outstanding, basic and diluted 131,627 124,117
126,583 122,600 (1) Includes the following
share-based compensation expense Cost of product sales,
license fees and royalties $ 838 $ 719 $ 3,863 $ 3,690 Research and
development $ 8,421 $ 7,887 $ 32,038 $ 26,485 Selling, general and
administrative $ 11,142 $ 13,413 $ 45,663 $ 45,357
ACADIA
PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31,2018
December 31,2017
(unaudited)
Assets Cash, cash equivalents and investment
securities $ 473,520 $ 341,342 Accounts receivable, net 26,090
17,343 Interest and other receivables 1,699 1,087 Inventory 4,070
5,248 Prepaid expenses 20,727 8,457 Total current
assets 526,106 373,477 Property and equipment, net 3,309 2,662
Intangible assets, net 4,062 5,538 Restricted cash 4,826 2,475
Other assets 1,899 354 Total assets $ 540,202 $
384,506
Liabilities and stockholders’ equity Accounts
payable $ 3,167 $ 8,786 Accrued liabilities 56,398
40,244 Total current liabilities 59,565 49,030 Long-term
liabilities 1,558 191 Total liabilities 61,123
49,221 Total stockholders’ equity 479,079
335,285 Total liabilities and stockholders’ equity $ 540,202 $
384,506
Important Safety Information and
Indication for NUPLAZID (pimavanserin)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
- Elderly patients with
dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death.
- NUPLAZID is not approved for the
treatment of patients with dementia-related psychosis unrelated to
the hallucinations and delusions associated with Parkinson’s
disease psychosis.
Contraindication: NUPLAZID is contraindicated in patients
with a history of a hypersensitivity reaction to pimavanserin or
any of its components. Rash, urticaria, and reactions consistent
with angioedema (e.g., tongue swelling, circumoral edema, throat
tightness, and dyspnea) have been reported.
QT Interval Prolongation: NUPLAZID prolongs the QT
interval. The use of NUPLAZID should be avoided in patients with
known QT prolongation or in combination with other drugs known to
prolong QT interval including Class 1A antiarrhythmics or Class 3
antiarrhythmics, certain antipsychotic medications, and certain
antibiotics. NUPLAZID should also be avoided in patients with a
history of cardiac arrhythmias, as well as other circumstances that
may increase the risk of the occurrence of torsade de pointes
and/or sudden death, including symptomatic bradycardia, hypokalemia
or hypomagnesemia, and presence of congenital prolongation of the
QT interval.
Adverse Reactions: The most common adverse reactions (≥2%
for NUPLAZID and greater than placebo) were peripheral edema (7% vs
2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination
(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs
<1%).
Drug Interactions: Coadministration with strong CYP3A4
inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce
NUPLAZID dose to 10 mg taken orally as one tablet once daily.
Coadministration with strong CYP3A4 inducers may reduce NUPLAZID
exposure. Monitor patients for reduced efficacy and an increase in
NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been
established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg taken
orally once daily, without titration.
Indication: NUPLAZID is an atypical antipsychotic
indicated for the treatment of hallucinations and delusions
associated with Parkinson’s disease psychosis.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088. You can also call ACADIA Pharmaceuticals Inc. at
1-844-4ACADIA (1-844-422-2342).
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please see the full Prescribing Information including Boxed
WARNING for NUPLAZID at
https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190226006107/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Elena Ridloff,
CFA(858) 558-2871ir@acadia-pharm.com
Media Contact:ACADIA Pharmaceuticals Inc.Maurissa Messier(858)
768-6068media@acadia-pharm.com
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Apr 2023 to Apr 2024