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ACADIA Pharmaceuticals Reports Second Quarter 2018 Financial Results

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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

Revenue
Net 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 Development
Research 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 Administrative
Selling, 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 Loss
For 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 Investments
At 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 Information
ACADIA 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 Pharmaceuticals
ACADIA 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 Statements
Statements 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 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.

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.

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