UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
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Date of report
(Date of earliest event reported):
August 8, 2017
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Commission File
Number:
000-50768
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ACADIA Pharmaceuticals Inc.
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(Exact name of
registrant as specified in its charter.)
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Delaware
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061376651
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(State or other
jurisdiction of incorporation or organization)
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(IRS Employer
Identification No.)
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3611 Valley Centre Drive, Suite 300, San Diego, California
92130
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(Address of
principal executive offices)
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858-558-2871
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(Registrant's
Telephone number)
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Not Applicable
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(Former Name or
Former Address, if Changed Since Last Report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the Registrant
under any of the following provisions (see General Instruction A.2.
below):
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[ ]
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
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[ ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
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[ ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
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[ ]
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR
240.12b-2)
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Emerging growth
company [ ]
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If an emerging
growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. [
]
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Item
2.02 Results
of Operations and Financial Condition.
On August 8, 2017,
ACADIA Pharmaceuticals Inc. issued a press release announcing its
financial results for the second quarter and six months ended June
30, 2017. A copy of this press release is furnished herewith as
Exhibit 99.1. Pursuant to the rules and regulations of the
Securities and Exchange Commission, such exhibit and the
information set forth therein and in this Item 2.02 have been
furnished and shall not be deemed "filed" for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the
"Exchange Act"), or otherwise subject to liability under that
section nor shall they be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such filing regardless of any general incorporation
language.
Item
9.01
Financial Statements and Exhibits.
(d) The
following exhibit is furnished herewith:
99.1 Press Release dated August 8, 2017.
99.1 Press Release dated August 8, 2017.
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SIGNATURES
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Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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ACADIA
Pharmaceuticals Inc.
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Date:
August 8, 2017
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By:
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/s/ Glenn F.
Baity
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Name: Glenn F. Baity
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Title: EVP, General Counsel &
Secretary
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Exhibit
Index
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Exhibit No.
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Description
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EX-99.1
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Press
Release dated August 8, 2017
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Exhibit
99.1
ACADIA Pharmaceuticals Reports
Second Quarter 2017 Financial Results
Second Quarter Net Sales Grew to $30.5 Million
Including $3.6 Million From Transition to Sell-In Method of
Accounting
SAN DIEGO, CA, August 8, 2017 – 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 unaudited financial results for the
second quarter ended June 30, 2017.
“Our
commercial efforts continue to drive strong financial performance
with solid market uptake for NUPLAZID in patients with
Parkinson’s disease psychosis,” said Steve Davis,
ACADIA’s President and Chief Executive Officer.
“Following positive data from our Phase II study in
Alzheimer’s disease psychosis and recently completed
End-of-Phase II meeting with the FDA, we are excited to start our
Phase III program in the next couple of months.”
During
the second quarter of 2017, ACADIA generated $30.5 million of net
product sales of NUPLAZID, which includes the one-time recognition
of $3.6 million associated with the transition to the sell-in
revenue recognition method of accounting from the sell-through
method.
Starting
with the second quarter of 2017, based on its determination it
had sufficient volume of activity to
reasonably estimate its allowances for rebates and chargebacks,
ACADIA began to recognize revenue at the point of sale to its
specialty pharmacy and specialty distributor partners, commonly
referred to as the “sell-in” revenue recognition
method. Previously, ACADIA had deferred the recognition of revenue
until it obtained evidence that its specialty partners had
dispensed the product to a patient or had sold the product to a
government facility, long-term care pharmacy or in-patient hospital
pharmacy. The $3.6 million one-time adjustment was deferred revenue
as of March 31, 2017 and represents product held by specialty
pharmacies and specialty distributors at such
date.
For comparison purposes, the following table presents
NUPLAZID’s pro forma quarterly net product sales under the
sell-in method, if ACADIA had been able to reasonably estimate its
allowances for rebates and chargebacks from the time of launch in
May 2016.
Pro Forma Reconciliation of Sell-Through to Sell-In
Method
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(in
millions)
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Three Months Ended
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June 30,
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September 30,
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December 31,
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March 31,
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June 30,
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2016
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2016
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2016
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2017
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2017
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NUPLAZID net sales, as reported1
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$0.1
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$5.3
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$12.0
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$15.3
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$30.5
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Difference2
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0.4
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1.2
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0.5
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1.5
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(3.6)
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Pro
forma NUPLAZID net sales, sell-in method
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$0.5
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$6.5
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$12.5
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$16.8
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$26.9
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1
Includes the net
sales as previously reported for the quarterly periods through
March 31, 2017 utilizing the sell-through revenue recognition
method.
2
Represents the
impact of recognizing the deferred revenue at period-end, net of
allowances for rebates and chargebacks, had the sales been
recognized in the quarter which the product was delivered to the
specialty pharmacies and distributors.
Recent Highlights
●
Conducted
End-of-Phase II meeting with the FDA on the Alzheimer’s
disease psychosis (AD Psychosis) program.
●
Abstract of Phase
II data with pimavanserin for AD Psychosis was accepted for
presentation at the Clinical Trials on Alzheimer’s Disease
meeting in early November 2017.
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Expanded
penetration into the long-term care market with the deployment of
an additional 25 long-term care specialists; ACADIA currently has
approximately 155 total sales specialists.
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NUPLAZID nominated
for the 11th Annual Prix Galien
Award for Best Pharmaceutical Agent.
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ACADIA named to
Forbes Magazine’s List of World’s Most Innovative
Growth Companies.
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Continue to advance
broad clinical development program with ongoing studies in
Alzheimer’s disease agitation, schizophrenia inadequate
response, schizophrenia negative symptoms, and major depressive
disorder.
Financial Results
Revenue
Net
product sales of NUPLAZID, which was first made available for
prescription starting in May 2016, were $30.5 million for the three
months ended June 30, 2017 compared to $0.1 million for the three
months ended June 30, 2016. For the six months ended June 30, 2017
and 2016, ACADIA reported NUPLAZID net product sales of $45.8
million and $0.1 million, respectively.
Research and Development
Research
and development expenses for the three months ended June 30, 2017
were $34.2 million, compared to $20.5 million for the same period
of 2016. For the six months ended June 30, 2017 and 2016, research
and development expenses were $69.6 million and $43.3 million,
respectively. The increase in research and development expenses
during the 2017 periods as compared to 2016 was primarily due to
increased clinical costs related to the schizophrenia and
depression studies ACADIA initiated in the fourth quarter of 2016.
The company also incurred additional personnel and related costs
associated with its expanded research and development organization
during 2017 as compared to 2016.
Selling, General and Administrative
Selling,
general and administrative expenses for the three months ended June
30, 2017 were $61.5 million, compared to $50.8 million for the same
period of 2016. For the six months ended June 30, 2017 and 2016,
selling, general and administrative expenses were $127.3 million
and $78.3 million, respectively. The increase in selling, general
and administrative expenses during the 2017 periods as compared to
2016 was primarily due to costs incurred to support ACADIA’s
commercial activities for NUPLAZID.
Net Loss
For the
three months ended June 30, 2017, ACADIA reported a net loss of
$67.4 million, or $0.55 per common share, compared to a net loss of
$71.3 million, or $0.63 per common share, for the same period
in2016. The net losses for the three months ended June 30, 2017 and
2016 included $18.2 million and $13.9 million,
respectively, of non-cash stock-based compensation expense. For the
six months ended June 30, 2017, ACADIA reported a net loss of
$155.3 million, or $1.27 per common share, compared to a net loss
of $121.1 million, or $1.08 per common share, for the same period
in 2016. The net losses for the six months ended June 30, 2017 and
2016 included $33.8 million and $25.8 million,
respectively, of non-cash stock-based compensation
expense.
Cash and Investments
At June
30, 2017, ACADIA’s cash, cash equivalents, and investment
securities totaled $417.3 million, compared to $529.0 million at
December 31, 2016.
2017 Financial Guidance
ACADIA
expects that full-year NUPLAZID net sales for 2017 will be between
$105 million and $115 million.
Conference Call and Webcast Information
ACADIA
management will review its second quarter financial results and
operations via conference call and webcast later 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
12799639). A telephone replay of the conference call may be
accessed through August 22, 2017 by dialing 855-859-2056 for
callers in the U.S. or Canada and 404-537-3406 for international
callers (reference passcode 12799639). 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, 2017.
About NUPLAZID®
(pimavanserin)
NUPLAZID
is the first and only FDA-approved treatment for hallucinations and
delusions associated with PD Psychosis. NUPLAZID is a
non-dopaminergic, selective serotonin inverse agonist
preferentially targeting 5-HT2A receptors that
are thought to play an important role in PD Psychosis. NUPLAZID is
an oral medicine taken once a day with a recommended dose of 34 mg
(two 17-mg tablets). ACADIA discovered 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 maintains a
website at www.acadia-pharm.com
to which we regularly post copies of our press releases as well as
additional information and through which interested parties can
subscribe to receive e-mail alerts.
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 guidance for fiscal year 2017
NUPLAZID net sales; the benefits to be derived from NUPLAZID
(pimavanserin); the utility of pimavanserin in indications other
than hallucinations and delusions associated with PD Psychosis; and
the timing or results of future studies involving pimavanserin.
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 for 2017, 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, 2016 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)
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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2017
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2016
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2017
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2016
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Revenues
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Product
sales, net
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$30,475
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$97
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$45,761
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$97
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Collaborative
revenue
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—
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—
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—
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4
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Total
revenues
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30,475
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97
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45,761
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101
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Operating expenses
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Cost
of product sales
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2,224
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526
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4,487
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526
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License
fees and royalties
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982
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248
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1,657
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248
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Research
and development
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34,180
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20,478
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69,589
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43,253
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Selling,
general and administrative
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61,523
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50,768
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127,268
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78,259
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Total
operating expenses
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98,909
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72,020
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203,001
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122,286
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Loss
from operations
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(68,434)
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(71,923)
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(157,240)
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(122,185)
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Interest
income, net
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993
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601
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1,956
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1,101
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Net
loss
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$(67,441)
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$(71,322)
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$(155,284)
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$(121,084)
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Net
loss per common share, basic and diluted
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$(0.55)
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$(0.63)
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$(1.27)
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$(1.08)
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Weighted
average common shares outstanding, basic and diluted
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122,122
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113,308
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121,888
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112,327
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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June 30,
2017
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December 31,
2016
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(unaudited)
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Assets
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Cash,
cash equivalents and investments
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$417,320
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$529,036
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Accounts
receivable, net
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11,594
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5,903
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Interest
and other receivables
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784
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1,237
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Inventory
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6,003
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4,175
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Prepaid
expenses
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8,044
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7,546
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Total
current assets
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443,745
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547,897
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Property
and equipment, net
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3,296
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3,081
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Intangible
assets, net
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6,277
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7,015
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Restricted
cash
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2,475
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2,375
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Other
assets
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522
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785
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Total
assets
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$456,315
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$561,153
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Liabilities and stockholders’
equity
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Accounts
payable
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$3,588
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$3,912
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Accrued
liabilities
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37,325
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36,029
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Deferred
revenue
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—
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2,644
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Total
current liabilities
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40,913
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42,585
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Long-term
liabilities
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262
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157
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Total
liabilities
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41,175
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42,742
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Total stockholders’
equity
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415,140
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518,411
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Total liabilities and
stockholders’
equity
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$456,315
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$561,153
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Important Safety Information and Indication for NUPLAZID
(pimavanserin) tablets
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
hypersensitivity reaction to pimavanserin or any of its components.
Reactions have included rash, urticaria, tongue swelling,
circumoral edema, and throat tightness.
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: Strong
CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID
concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4
inducers may reduce NUPLAZID exposure, monitor for reduced
efficacy. Increase in NUPLAZID dosage may be needed.
Renal
Impairment: No dosage adjustment for NUPLAZID is needed in patients
with mild to moderate renal impairment. Use of NUPLAZID is not
recommended in patients with severe renal impairment.
Hepatic
Impairment: Use of NUPLAZID is not recommended in patients with
hepatic impairment. NUPLAZID has not been evaluated in this patient
population.
Pregnancy:
Use of NUPLAZID in pregnant women has not been evaluated and should
therefore be used in pregnancy only if the potential benefit
justifies the potential risk to the mother and fetus.
Pediatric
Use: Safety and efficacy have not been established in pediatric
patients.
Dosage
and Administration: Recommended dose: 34 mg per
day, taken orally as two 17-mg tablets once daily, without
titration.
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.
Investor
Contact:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy
(858) 558-2871
ir@acadia-pharm.com
Media
Contact:
Taft Communications
Bob Laverty
(609) 558-5570
bob@taftcommunications.com