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 27, 2018
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))
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)
Emerging growth company [ ]
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. [ ]
Item 2.02 Results of Operations and Financial Condition.
On February 27, 2018, ACADIA Pharmaceuticals Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 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 February 27, 2018
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 27, 2018
| By: | /s/ Glenn F. Baity |
| Name: Glenn F. Baity | |
| Title: Executive Vice President, General Counsel & Secretary |
Exhibit Index
|
Exhibit No.
|
Description
|
|
|
EX-99.1
|
Press release dated February 27, 2018
|
ACADIA Pharmaceuticals Reports
Fourth Quarter and Full Year 2017
Financial Results
-Fourth Quarter and Full Year 2017 Net Sales Grew to $43.6 Million
and $124.9 Million, Respectively
SAN DIEGO, CA, February 27, 2018 – 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, 2017.
“Our
2017 results reflect the robust uptake of NUPLAZID (pimavanserin)
in the treatment of Parkinson’s disease psychosis,”
said Steve Davis, ACADIA’s President and Chief Executive
Officer. “We were also very pleased to receive Breakthrough
Therapy Designation from the FDA as we explore the utility of
pimavanserin in dementia-related psychosis, where no drug is
currently approved. This is the second Breakthrough Therapy
Designation for pimavanserin.”
“As
we look to 2018, we anticipate continued strong volume growth for
NUPLAZID. In addition, we look forward to advancing our late-stage
clinical programs in dementia-related psychosis, schizophrenia
inadequate response and schizophrenia negative symptoms, as well as
sharing the top-line results of our CLARITY study in major
depressive disorder in the second half of 2018.”
Recent Highlights
●
Initiated a
national direct-to-consumer disease awareness TV ad campaign to
educate patients and caregivers about Parkinson’s disease
psychosis (PD Psychosis) in November 2017.
●
Initiated pivotal
Phase 3 HARMONY Study with pimavanserin in dementia-related
psychosis in October 2017.
●
Received a second
Breakthrough Therapy Designation from the FDA for pimavanserin in
October 2017. This designation is for the treatment of
dementia-related psychosis.
●
Presented Phase 2
data with pimavanserin in Alzheimer’s disease psychosis at
the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in
Boston in November 2017.
●
Appointed Damien
McDevitt, Ph.D., Senior Vice President, Corporate
Development.
Financial Results
Revenue
Net
product sales of NUPLAZID, which was first made available for
prescription starting in May 2016, were $43.6 million for the
fourth quarter of 2017, an increase of 263% as compared to $12.0
million reported for the fourth quarter of 2016. For the year ended
December 31, 2017, ACADIA reported NUPLAZID net product sales of
$124.9 million, an increase of $107.6 million, or 622% from the
$17.3 million reported for the year ended December 31,
2016.
Research and Development
Research
and development expenses for the fourth quarter of 2017 were $43.2
million, compared to $30.2 million for the same period of 2016. For
the year ended December 31, 2017 and 2016, research and development
expenses were $149.2 million and $99.3 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 clinical studies initiated in the fourth
quarter of each of 2016 and 2017. 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 fourth quarter of 2017
were $66.7 million, compared to $57.7 million for the same period
of 2016. For the year ended December 31, 2017 and 2016,
selling, general and administrative expenses were $255.1 million
and $186.5 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, including additional personnel
and related costs, together with increased contributions to
third-party charitable foundations that support Parkinson’s
disease patients.
Net Loss
For the
fourth quarter of 2017, ACADIA reported a net loss of $68.9
million, or $0.55 per common share, compared to a net loss of $78.7
million, or $0.65 per common share, for the same period in 2016.
The net losses for the fourth quarter of 2017 and 2016
included $22.0 million and $15.4 million,
respectively, of non-cash stock-based compensation expense. For the
year ended December 31, 2017, ACADIA reported a net loss of
$289.4 million, or $2.36 per common share, compared to a net loss
of $271.4 million, or $2.34 per common share, for the same period
in 2016. The net losses for the year ended December 31, 2017
and 2016 included $75.5 million and $55.3 million,
respectively, of non-cash stock-based compensation
expense.
Cash and Investments
At
December 31, 2017, ACADIA’s cash, cash equivalents and
investment securities totaled $341.3 million, compared to $529.0
million at December 31, 2016.
2018 Financial Guidance
ACADIA
expects that full-year NUPLAZID net product sales for 2018 will be
between $255 million and $270 million, with net sales for the first
quarter of 2018 between $45 million and $48 million. The company
expects to end 2018 with more than $200 million of cash, cash
equivalents and investment securities on its balance
sheet.
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
8377668). A telephone replay of the conference call may be accessed
through March 13, 2018 by dialing 855-859-2056 for callers in the
U.S. or Canada and 404-537-3406 for international callers
(reference passcode 8377668). 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
March 13, 2018.
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 first quarter and
full-year 2018 NUPLAZID net sales; future strong volume growth for
NUPLAZID; the benefits to be derived from NUPLAZID; whether
NUPLAZID will be useful in other indications; and the timing of
ongoing clinical studies and the timing of reporting of results
from our study in major depressive disorder. 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 December 31,
|
Years Ended December 31,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
Revenues
|
|
|
|
|
|
Product
sales, net
|
$43,562
|
$11,962
|
$124,901
|
$17,327
|
|
Collaborative
revenue
|
—
|
—
|
—
|
4
|
|
Total
revenues
|
43,562
|
11,962
|
124,901
|
17,331
|
|
Operating expenses
|
|
|
|
|
|
Cost
of product sales
|
2,455
|
1,704
|
9,077
|
3,075
|
|
License
fees and royalties
|
1,248
|
608
|
3,983
|
1,331
|
|
Research
and development
|
43,179
|
30,218
|
149,189
|
99,284
|
|
Selling,
general and administrative
|
66,689
|
57,663
|
255,062
|
186,456
|
|
Total
operating expenses
|
113,571
|
90,193
|
417,311
|
290,146
|
|
Loss
from operations
|
(70,009)
|
(78,231)
|
(292,410)
|
(272,815)
|
|
Interest
income, net
|
1,107
|
876
|
4,126
|
2,763
|
|
Loss
before income taxes
|
(68,902)
|
(77,355)
|
(288,284)
|
(270,052)
|
|
Income
tax expense
|
(31)
|
1,341
|
1,119
|
1,341
|
|
Net
loss
|
$(68,871)
|
$(78,696)
|
$(289,403)
|
$(271,393)
|
|
Net
loss per common share, basic and diluted
|
$(0.55)
|
$(0.65)
|
$(2.36)
|
$(2.34)
|
|
Weighted
average common shares outstanding, basic and diluted
|
124,117
|
121,202
|
122,600
|
115,858
|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
December 31,
2017
|
December 31,
2016
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Cash,
cash equivalents and investment securities
|
$341,342
|
$529,036
|
|
Accounts
receivable, net
|
17,343
|
5,903
|
|
Interest
and other receivables
|
1,087
|
1,237
|
|
Inventory
|
5,248
|
4,175
|
|
Prepaid
expenses
|
8,457
|
7,546
|
|
Total
current assets
|
373,477
|
547,897
|
|
Property
and equipment, net
|
2,662
|
3,081
|
|
Intangible
assets, net
|
5,538
|
7,015
|
|
Restricted
cash
|
2,475
|
2,375
|
|
Other
assets
|
354
|
785
|
|
Total
assets
|
$384,506
|
$561,153
|
|
Liabilities and stockholders’ equity
|
|
|
|
Accounts
payable
|
$8,786
|
$3,912
|
|
Accrued
liabilities
|
40,244
|
36,029
|
|
Deferred
revenue
|
—
|
2,644
|
|
Total
current liabilities
|
49,030
|
42,585
|
|
Long-term
liabilities
|
191
|
157
|
|
Total
liabilities
|
49,221
|
42,742
|
|
Total
stockholders’ equity
|
335,285
|
518,411
|
|
Total
liabilities and stockholders’ equity
|
$384,506
|
$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 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: 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