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
Date of report (Date of earliest event reported): February 28, 2017
Commission File Number: 000-50768
ACADIA Pharmaceuticals Inc.
(Exact name of registrant as specified in its charter.)
(Exact name of registrant as specified in its charter.)
Delaware
(State or other jurisdiction of incorporation or organization)
(State or other jurisdiction of incorporation or organization)
061376651
(IRS Employer Identification No.)
(IRS Employer Identification No.)
3611 Valley Centre Drive, Suite 300, San Diego, California 92130
(Address of principal executive offices)
(Address of principal executive offices)
858-558-2871
(Registrant's Telephone number)
(Registrant's Telephone number)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
(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):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On February 28, 2017, ACADIA Pharmaceuticals Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2016. 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 February 28, 2017
SIGNATURES
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.
| ACADIA Pharmaceuticals Inc. |
Date: February 28, 2017
| By: | /s/ Glenn F. Baity |
| Name: Glenn F. Baity | |
| Title: EVP, General Counsel & Secretary |
Exhibit Index
|
Exhibit No.
|
Description
|
|
|
EX-99.1
|
Press release dated February 28, 2017
|
ACADIA Pharmaceuticals Reports Financial Results for the Fourth
Quarter and Year Ended December 31, 2016
NUPLAZID® Net Product
Sales Grew to $12.0 Million in Fourth Quarter 2016
Executing on Broad Clinical Development Program in
Alzheimer’s Disease Psychosis, Alzheimer’s Disease
Agitation, Schizophrenia Inadequate Response, Negative Symptoms of
Schizophrenia, and Major Depressive Disorder
SAN DIEGO, CA February 28, 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 financial
results for the fourth quarter and year ended December 31,
2016.
“2016
was a transformational year for ACADIA highlighted by the launch of
NUPLAZID (pimavanserin) as the first and only drug approved by the
FDA for the treatment of hallucinations and delusions associated
with Parkinson’s disease psychosis,” said Steve Davis,
ACADIA’s President and Chief Executive Officer. “We are
pleased with the strong progress of the launch and our execution in
bringing this drug to Parkinson’s
patients.”
“More
recently, we announced positive results from our Phase II study
with pimavanserin in Alzheimer’s disease psychosis.
Pimavanserin has now shown antipsychotic effects in clinical
studies in three major CNS disorders: Parkinson’s disease,
schizophrenia, and Alzheimer’s disease. These results,
combined with the initiation of four new clinical programs,
underscore the potential of pimavanserin to improve the lives of
patients across multiple CNS disease states and our commitment to
explore this potential in broad and substantive clinical
programs.”
Recent
Highlights
●
NUPLAZID now
available on Medicare formularies for the treatment of
Parkinson’s disease psychosis (PD Psychosis); commercial
coverage decisions now made for over 60% of commercial lives and
continue to grow.
●
Positive top-line
results from our Phase II study exploring the utility of
pimavanserin for the treatment of Alzheimer’s disease
psychosis announced in December 2016.
●
Initiated the
SERENE study, a 430-patient study evaluating pimavanserin for the
treatment of Alzheimer’s disease agitation.
●
Initiated the
ENHANCE-1 study, a 380-patient study evaluating pimavanserin for
adjunctive treatment of schizophrenia in patients with an
inadequate response to their current antipsychotic
therapy.
●
Initiated the
ADVANCE study, a 380-patient study evaluating pimavanserin for
adjunctive treatment in patients with negative symptoms of
schizophrenia.
●
Initiated the
CLARITY study, a 188-patient study evaluating pimavanserin for
adjunctive treatment in patients with major depressive disorder who
have an inadequate response to standard antidepressant
therapy.
Financial
Results
Revenue
ACADIA
reported net product sales of $12.0 million for the fourth quarter
of 2016. NUPLAZID was launched commercially in May 2016, so there
were no similar product sales for the comparable quarter of 2015.
Through ACADIA’s NUPLAZIDconnectTM site, upon
initiation of therapy, physicians have been able to prescribe
patients a 30-day free trial of NUPLAZID for which no revenue is
recognized.
Research and Development
Research and
development expenses increased to $30.2 million for the fourth
quarter of 2016 from $20.5 million for the comparable quarter of
2015. This increase was primarily due to increased clinical costs
related to the development of pimavanserin in indications other
than PD Psychosis and an increase in personnel and related costs
associated with ACADIA’s expanded research and development
organization.
Selling, General and Administrative
Selling, general
and administrative expenses increased to $57.7 million for the
fourth quarter of 2016 from $22.6 million for the comparable
quarter of 2015. This increase was primarily due to costs related
to the hiring of our specialty sales force in April 2016 and costs
incurred to support our commercial activities for
NUPLAZID.
Net Loss
For the
fourth quarter of 2016, ACADIA reported a net loss of $78.7
million, or $0.65 per common share, compared to a net loss of $45.8
million, or $0.45 per common share, for the comparable quarter of
2015. The net losses for the fourth quarters of 2016 and 2015
included $15.4 million and $8.9 million, respectively, of non-cash
stock-based compensation expense. For the year ended December 31,
2016, ACADIA reported a net loss of $271.4 million, or $2.34 per
common share, compared to a net loss of $164.4 million, or $1.63
per common share, for 2015. The net losses for the years ended
December 31, 2016 and 2015 included $55.3 million and $40.2
million, respectively, of non-cash stock-based compensation
expense.
Cash and Investments
At
December 31, 2016, ACADIA’s cash, cash equivalents and
investment securities totaled $529.0 million, compared to $215.1
million at December 31, 2015.
Conference Call and Webcast Information
ACADIA
management will review its fourth 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
74539512). A telephone replay of the conference call may be
accessed through March 14, 2017 by dialing 855-859-2056 for callers
in the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 74539512). 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 until March
14, 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 the benefits to be derived
from NUPLAZID (pimavanserin); the potential of pimavanserin to
improve the lives of patients across multiple CNS disease states
and our commitment to explore this potential in broad and
substantive clinical programs; and the utility of pimavanserin in
indications other than hallucinations and delusions associated with
PD Psychosis.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 risks and uncertainties inherent in drug discovery,
development, 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)
|
|
Three Months Ended
December 31,
|
Years Ended
December 31,
|
||
|
|
2016
|
2015
|
2016
|
2015
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
Product
sales, net
|
$11,962
|
$—
|
$17,327
|
$—
|
|
Collaborative
revenues
|
—
|
17
|
4
|
61
|
|
Total
revenues
|
11,962
|
17
|
17,331
|
61
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
Cost
of product sales
|
1,704
|
—
|
3,075
|
—
|
|
License
fees and royalties
|
608
|
2,500
|
1,331
|
2,500
|
|
Research
and development
|
30,218
|
20,466
|
99,284
|
73,869
|
|
Selling,
general and administrative
|
57,663
|
22,616
|
186,456
|
88,304
|
|
Total
operating expenses
|
90,193
|
45,582
|
290,146
|
164,673
|
|
Loss
from operations
|
(78,231)
|
(45,565)
|
(272,815)
|
(164,612)
|
|
Interest
income, net
|
876
|
111
|
2,763
|
499
|
|
Loss
before income taxes
|
(77,355)
|
(45,454)
|
(270,052)
|
(164,113)
|
|
Income
tax expense
|
1,341
|
330
|
1,341
|
330
|
|
Net
loss
|
$(78,696)
|
$(45,784)
|
$(271,393)
|
$(164,443)
|
|
Net
loss per common share, basic and diluted
|
$(0.65)
|
$(0.45)
|
$(2.34)
|
$(1.63)
|
|
Weighted
average common shares outstanding, basic and diluted
|
121,202
|
101,207
|
115,858
|
100,630
|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
|
|
December 31,
|
|
|
|
2016
|
2015
|
|
Assets
|
|
|
|
Cash,
cash equivalents, and investment securities
|
$529,036
|
$215,132
|
|
Accounts
receivable, net
|
5,903
|
—
|
|
Interest
and other receivables
|
1,237
|
1,638
|
|
Inventory
|
4,175
|
—
|
|
Prepaid
expenses and other current assets
|
7,546
|
2,219
|
|
Total
current assets
|
547,897
|
218,989
|
|
Property
and equipment, net
|
3,081
|
2,203
|
|
Intangible
assets, net
|
7,015
|
—
|
|
Restricted
cash
|
2,375
|
375
|
|
Other
assets
|
785
|
329
|
|
Total
assets
|
$561,153
|
$221,896
|
|
Liabilities and stockholders’ equity
|
|
|
|
Accounts
payable
|
$3,912
|
$1,672
|
|
Accrued
liabilities
|
36,029
|
20,230
|
|
Deferred
revenue
|
2,644
|
—
|
|
Total
current liabilities
|
42,585
|
21,902
|
|
Long-term
liabilities
|
157
|
232
|
|
Total
liabilities
|
42,742
|
22,134
|
|
Total
stockholders’ equity
|
518,411
|
199,762
|
|
Total
liabilities and stockholders’ equity
|
$561,153
|
$221,896
|
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.
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