–Second Quarter Net Sales Grew to $57.1
Million, Representing a 17% Sequential Increase Over 1Q18 and 87%
Increase Over 2Q17
–Announced FDA Approval of New Dosing
Formulation and Strength of NUPLAZID® (Pimavanserin)
–Expanded ACADIA’s Pipeline in Central Nervous
System Disorders with Exclusive License Agreement for the North
American Development and Commercialization of Trofinetide
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 second quarter ended June 30, 2018.
“In the second quarter, NUPLAZID delivered 17% revenue growth
and 3% sequential volume growth. We remain focused on our
initiatives to provide physicians, patients and caregivers access
to NUPLAZID’s robust safety and efficacy data and to improve the
lives of patients living with Parkinson’s disease psychosis,” said
Steve Davis, ACADIA’s President and Chief Executive Officer. “We
are building on our foundation of bringing innovative CNS therapies
to market with the launch of the 34 mg capsule for NUPLAZID this
month and the advancement of our four late-stage clinical programs
for pimavanserin with top-line results from our Phase 2 study in
major depressive disorder expected in the fourth quarter of 2018.
In addition, we are pleased to have recently expanded our pipeline
through a license agreement to develop and commercialize
trofinetide in North America for the potential treatment of Rett
syndrome and other CNS disorders.”
Recent Highlights
- Announced an exclusive license
agreement with Neuren Pharmaceuticals (ASX: NEU) for the North
American development and commercialization of trofinetide for all
indications, including Rett syndrome, a rare neurodevelopmental CNS
disorder. Trofinetide is a novel synthetic analog of the
amino-terminal tripeptide of IGF-1 designed to treat the core
symptoms of Rett syndrome by reducing neuroinflammation and
supporting synaptic function.
- Announced FDA approval of a new 34 mg
single capsule formulation of NUPLAZID to help in the treatment of
patients living with hallucinations and delusions associated with
Parkinson’s disease psychosis.
- Completed enrollment in the Phase 2
CLARITY study assessing pimavanserin as a potential adjunctive
treatment for major depressive disorder.
- Appointed Austin D. Kim as Executive
Vice President, General Counsel and Secretary.
Financial Results
RevenueNet sales of NUPLAZID were $57.1 million for the three
months ended June 30, 2018, an increase of 87% as compared to $30.5
million reported for the three months ended June 30, 2017. For the
six months ended June 30, 2018 and 2017, ACADIA reported net
product sales of $105.9 million and $45.8 million,
respectively.
Research and DevelopmentResearch and development expenses for
the three months ended June 30, 2018 were $46.6 million, compared
to $34.2 million for the same period of 2017. For the six months
ended June 30, 2018 and 2017, research and development expenses
were $85.9 million and $69.6 million, respectively. The increase in
research and development expenses during the 2018 period as
compared to 2017 was primarily due to additional clinical study
costs incurred by the Company as it continues to invest in its life
cycle management programs for pimavanserin and costs incurred
related to the development of the 34 mg capsule and 10 mg tablet of
NUPLAZID.
Selling, General and AdministrativeSelling, general and
administrative expenses for the three months ended June 30, 2018
were $69.5 million, compared to $61.1 million for the same period
of 2017. For the six months ended June 30, 2018 and 2017, selling
general and administrative expenses were $130.4 million and $126.8
million, respectively. The increase in selling, general and
administrative expenses during the 2018 period as compared to 2017
was primarily due to an increase in external selling, general and
administrative expenses related to the Company’s direct-to-consumer
disease awareness campaign.
Net LossFor the three months ended June 30, 2018, ACADIA
reported a net loss of $63.3 million, or $0.51 per common share,
compared to a net loss of $67.4 million, or $0.55 per common share,
for the same period in 2017. The net losses for the three months
ended June 30, 2018 and 2017 included $20.6
million and $18.2 million, respectively, of non-cash
stock-based compensation expense. For the six months ended June 30,
2018, ACADIA reported a net loss of $117.6 million, or $0.94 per
common share, compared to a net loss of $155.3 million, or $1.27
per common share, for the same period in 2017. The net losses for
the six months ended June 30, 2018 and 2017 included $41.0 million
and $33.8 million, respectively, of non-cash stock-based
compensation expense.
Cash and InvestmentsAt June 30, 2018, ACADIA’s cash, cash
equivalents and investment securities totaled $256.9 million,
compared to $341.3 million at December 31, 2017.
Financial Guidance
ACADIA is lowering its 2018 NUPLAZID net sales guidance to be
between $210 million and $225 million from a previous range of $255
million to $270 million.
For the third quarter of 2018, ACADIA expects NUPLAZID net sales
to be between $52 million and $59 million.
ACADIA is lowering its guidance for its year end 2018 cash, cash
equivalents and investment securities on its balance sheet to be
between $155 million to $170 million from previous guidance of over
$200 million. This updated guidance is inclusive of the $10 million
upfront fee and initial research and development expenses for
trofinetide.
Conference Call and Webcast InformationACADIA management will
review its first quarter 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 844-821-1109 for
participants in the U.S. or Canada and 830-865-2550 for
international callers (reference passcode 7987107). A telephone
replay of the conference call may be accessed through August 22,
2018 by dialing 855-859-2056 for callers in the U.S. or Canada and
404-537-3406 for international callers (reference passcode
7987107). 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 August 22, 2018.
About NUPLAZID® (pimavanserin)NUPLAZID is the
first FDA-approved treatment for hallucinations and delusions
associated with Parkinson’s disease psychosis. NUPLAZID is a
non-dopaminergic, selective serotonin inverse agonist
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 results from our study in major depressive
disorder and the timing of other ongoing clinical studies; the
development and commercialization of trofinetide; and guidance for
third quarter 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 2018, 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 June 30, Six Months Ended June
30, 2018 2017 2018
2017 Revenues Product sales, net
$ 57,063 $ 30,475 $ 105,931 $ 45,761 Total revenues 57,063 30,475
105,931 45,761
Operating expenses Cost of product sales,
license fees and royalties 5,078 3,206 8,563 6,144 Research and
development 46,592 34,180 85,868 69,589 Selling, general and
administrative 69,472 61,125 130,398
126,785 Total operating expenses 121,142 98,511
224,829 202,518 Loss from operations (64,079 )
(68,036 ) (118,898 ) (156,757 ) Interest income, net 1,279 993
2,449 1,956 Other expense (247 ) — (247 )
— Loss before income taxes (63,047 ) (67,043 ) (116,696 )
(154,801 ) Income tax expense 219 398 866
483 Net loss $ (63,266 ) $ (67,441 ) $ (117,562 ) $ (155,284
) Net loss per common share, basic and diluted $ (0.51 ) $ (0.55 )
$ (0.94 ) $ (1.27 ) Weighted average common shares outstanding,
basic and diluted 124,910 122,122 124,819
121,888
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
June 30,
2018
December 31,
2017
(unaudited)
Assets Cash, cash equivalents and investment
securities $ 256,855 $ 341,342 Accounts receivable, net 25,696
17,343 Interest and other receivables 986 1,087 Inventory 4,737
5,248 Prepaid expenses 12,822 8,457 Total current
assets 301,096 373,477 Property and equipment, net 2,760 2,662
Intangible assets, net 4,800 5,538 Restricted cash 3,111 2,475
Other assets 3,193 354 Total assets $ 314,960 $
384,506
Liabilities and stockholders’ equity Accounts
payable $ 3,333 $ 8,786 Accrued liabilities 45,881
40,244 Total current liabilities 49,214 49,030 Long-term
liabilities 1,026 191 Total liabilities 50,240
49,221 Total stockholders’ equity 264,720
335,285 Total liabilities and stockholders’ equity $ 314,960 $
384,506
Important Safety Information and
Indication for NUPLAZID (pimavanserin)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSISElderly 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.
NUPLAZID is an atypical antipsychotic indicated for the
treatment of 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.
NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg
tablets.
For additional Important Safety Information, including Boxed
WARNING, please see the full Prescribing Information for NUPLAZID
at
https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180808005590/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Elena Ridloff,
CFA(858) 558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsBob Laverty(609)
558-5570bob@taftcommunications.com
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