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): May 9, 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 May 9, 2017, ACADIA Pharmaceuticals Inc. issued a press release announcing its financial results for the first quarter and three months ended March 31, 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 May 9, 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: May 9, 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 May 9, 2017.
|
ACADIA Pharmaceuticals Reports
First Quarter 2017 Financial Results
SAN DIEGO, CA May 9, 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
first quarter ended March 31, 2017.
“We’re
very pleased with our strong start to 2017,” said Steve
Davis, ACADIA’s President and Chief Executive Officer.
“The use of NUPLAZID® in
Parkinson’s disease psychosis continues to
expand as brand awareness among neurologists, psychiatrists, and
other healthcare providers grows. We also continue to advance our
ongoing clinical studies in Alzheimer’s disease agitation,
schizophrenia inadequate response, schizophrenia negative symptoms,
and major depressive disorder, and we look forward to moving our
Alzheimer’s disease psychosis program into Phase III in the
second half of 2017.”
Recent Highlights
●
Net revenue for the
first quarter of 2017 of $15.3 million, an increase of 28% from the
fourth quarter of 2016.
●
NUPLAZID
(pimavanserin) available on Medicare formularies for the treatment
of Parkinson’s disease psychosis (PD Psychosis); commercial
coverage decisions grew to over 90% of commercial
lives.
●
Expanded
penetration into the long-term care market with 25 additional
long-term care sales specialists; ACADIA currently has
approximately 155 total sales specialists.
●
Continued to
execute on broad clinical development program with ongoing studies
in Alzheimer’s disease agitation, schizophrenia inadequate
response, schizophrenia negative symptoms, and major depressive
disorder.
●
Plan to advance
Alzheimer’s disease psychosis (AD Psychosis) program into
Phase III in second half of 2017.
●
Presented data on
NUPLAZID in PD Psychosis at the American Association for Geriatric
Psychiatry Annual Meeting.
●
Appointed Michael
J. Yang as Executive Vice President, Chief Commercial
Officer.
Financial Results
Revenue
ACADIA
reported NUPLAZID net product sales of $15.3 million for the three
months ended March 31, 2017. NUPLAZID was first made available for
prescription starting in May 2016 and there were no similar net
product sales for the comparable period of 2016. ACADIA reports
product sales when its specialty pharmacy partners dispense
NUPLAZID to a patient based on the fulfillment of a prescription or
its specialty distributor partners sell NUPLAZID to a government
facility, long-term care pharmacy or in-patient hospital pharmacy.
As of March 31, 2017, the company had $4.1 million of deferred
product revenue, net of distribution fees, for product it had
shipped to its distribution partners that had not yet sold-through
the distribution channel. At December 31, 2016, the company had
$2.6 million of deferred product revenue, net of distribution
fees.
Research and Development
Research
and development expenses increased to $35.4 million for the three
months ended March 31, 2017 from $22.8 million for the comparable
period of 2016. This increase was primarily due to increased
clinical costs related to studies the company initiated in the
fourth quarter of 2016 for indications other than PD Psychosis. The
company also incurred additional personnel and related costs
associated with its expanded research and development organization
during the three months ended March 31, 2017 compared to the same
period in 2016.
Selling, General and Administrative
Selling,
general and administrative expenses increased to $65.7 million for
the three months ended March 31, 2017 from $27.5 million for the
comparable period of 2016. This increase was primarily due to costs
incurred to support ACADIA’s commercial activities for
NUPLAZID and costs related to its specialty sales force that did
not exist for the comparable period of 2016 prior to the launch of
NUPLAZID.
Net Loss
For the
three months ended March 31, 2017, ACADIA reported a net loss of
$87.8 million, or $0.72 per common share, compared to a net loss of
$49.8 million, or $0.45 per common share, for the comparable period
of 2016. The net loss for the three months ended March 31, 2017
included $15.6 million of non-cash stock-based compensation expense
compared to $12.0 million for the comparable period of
2016.
Cash and Investments
At
March 31, 2017, ACADIA’s cash, cash equivalents, and
investment securities totaled $469.5 million, compared to $529.0
million at December 31, 2016.
Conference Call and Webcast Information
ACADIA
management will review its first 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
12435244). A telephone replay of the conference call may be
accessed through May 23, 2017 by dialing 855-859-2056 for callers
in the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 12435244). 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 May
23, 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 utility of pimavanserin in
indications other than hallucinations and delusions associated with
PD Psychosis; and 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
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
March 31,
|
|
|
|
2017
|
2016
|
|
|
|
|
|
Revenues
|
|
|
|
Product
sales, net
|
$15,286
|
$—
|
|
Collaborative
revenue
|
—
|
4
|
|
Total
revenues
|
15,286
|
4
|
|
|
|
|
|
Operating expenses
|
|
|
|
Cost
of product sales
|
2,263
|
—
|
|
License
fees and royalties
|
675
|
—
|
|
Research
and development
|
35,409
|
22,775
|
|
Selling,
general and administrative
|
65,745
|
27,491
|
|
Total
operating expenses
|
104,092
|
50,266
|
|
Loss
from operations
|
(88,806)
|
(50,262)
|
|
Interest
income, net
|
963
|
500
|
|
Net
loss
|
$(87,843)
|
$(49,762)
|
|
Net
loss per common share, basic and diluted
|
$(0.72)
|
$(0.45)
|
|
Weighted
average common shares outstanding, basic and diluted
|
121,651
|
111,346
|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
March 31,
2017
|
December 31,
2016
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Cash,
cash equivalents, and investment securities
|
$469,481
|
$529,036
|
|
Accounts
receivable, net
|
7,660
|
5,903
|
|
Interest
and other receivables
|
1,859
|
1,237
|
|
Inventory
|
3,881
|
4,175
|
|
Prepaid
expenses
|
6,872
|
7,546
|
|
Total
current assets
|
489,753
|
547,897
|
|
Property
and equipment, net
|
3,471
|
3,081
|
|
Intangible
assets, net
|
6,646
|
7,015
|
|
Restricted
cash
|
2,475
|
2,375
|
|
Other
assets
|
668
|
785
|
|
Total
assets
|
$503,013
|
$561,153
|
|
Liabilities and stockholders’ equity
|
|
|
|
Accounts
payable
|
$2,166
|
$3,912
|
|
Accrued
liabilities
|
38,967
|
36,029
|
|
Deferred
revenue
|
4,132
|
2,644
|
|
Total
current liabilities
|
45,265
|
42,585
|
|
Long-term
liabilities
|
224
|
157
|
|
Total
liabilities
|
45,489
|
42,742
|
|
Total
stockholders’ equity
|
457,524
|
518,411
|
|
Total
liabilities and stockholders’ equity
|
$503,013
|
$561,153
|
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