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): November 7, 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))
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 November 7, 2017, ACADIA Pharmaceuticals Inc. issued a press release announcing its financial results for the third quarter and nine months ended September 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 November 7, 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: November 7, 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 November 7, 2017
|
Exhibit 99.1
ACADIA
Pharmaceuticals Reports
Third Quarter 2017 Financial
Results
-Third Quarter
Net Sales Grew to $35.6 Million
-Company Raises
Annual 2017 Net Sales Guidance to Between $124 Million and $127
Million
SAN DIEGO, CA, November 7, 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 third quarter ended September 30, 2017.
“Our
results this quarter reflect strong growth for NUPLAZID for
Parkinson’s disease psychosis,” said Steve Davis,
ACADIA’s President and Chief Executive Officer. “We
also recently advanced our clinical portfolio with the initiation
of our Phase III study of pimavanserin for dementia-related
psychosis and were pleased to receive FDA Breakthrough Therapy
Designation for this program. If this study is successful, we
believe pimavanserin will provide an important benefit to patients
with dementia-related psychosis who currently have no FDA-approved
treatments available to them.”
Recent Highlights
●
Initiated pivotal
Phase III HARMONY Study with pimavanserin in dementia-related
psychosis in October 2017.
●
FDA granted
Breakthrough Therapy Designation to pimavanserin for the treatment
of dementia-related psychosis in October 2017. This is the second
Breakthrough Therapy Designation for pimavanserin.
●
Presented Phase II
data with pimavanserin in Alzheimer’s disease psychosis at
the Symposium, “The Importance of Serotonin in
Alzheimer’s Disease Psychosis and the Role of
Pimavanserin,” at the Clinical Trials on Alzheimer’s
Disease (CTAD) meeting in Boston in November 2017.
●
In addition to
dementia-related psychosis, ACADIA continues to advance its broad
clinical development program with ongoing studies in 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 $35.6 million for the three
months ended September 30, 2017 compared to $5.3 million for the
three months ended September 30, 2016. For the nine months ended
September 30, 2017 and 2016, ACADIA reported NUPLAZID net product
sales of $81.3 million and $5.4 million, respectively.
Research and Development
Research
and development expenses for the three months ended September 30,
2017 were $36.4 million, compared to $25.8 million for the same
period of 2016. For the nine months ended September 30, 2017 and
2016, research and development expenses were $106.0 million and
$69.1 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 three months ended
September 30, 2017 were $62.3 million, compared to $50.5 million
for the same period of 2016. For the nine months ended September
30, 2017 and 2016, selling, general and administrative expenses
were $189.5 million and $128.8 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 and due to
increased charitable contributions.
Net Loss
For the
three months ended September 30, 2017, ACADIA reported a net loss
of $65.2 million, or $0.53 per common share, compared to a net loss
of $71.6 million, or $0.61 per common share, for the same period in
2016. The net losses for the three months ended September 30, 2017
and 2016 included $19.7 million and $14.0 million,
respectively, of non-cash stock-based compensation expense. For the
nine months ended September 30, 2017, ACADIA reported a net loss of
$220.5 million, or $1.81 per common share, compared to a net loss
of $192.7 million, or $1.69 per common share, for the same period
in 2016. The net losses for the nine months ended September 30,
2017 and 2016 included $53.5 million and $39.8
million, respectively, of non-cash stock-based compensation
expense.
Cash and Investments
At
September 30, 2017, ACADIA’s cash, cash equivalents and
investment securities totaled $366.6 million, compared to $529.0
million at December 31, 2016.
2017 Financial Guidance
ACADIA
is increasing its revenue guidance and now expects that full-year
NUPLAZID net sales for 2017 will be between $124 million and $127
million.
Pro Forma Reconciliation of Sell-Through to Sell-In
Method
In the
second quarter of 2017 the company 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, commonly referred to as the “sell-through”
revenue recognition method. As a result of this change, ACADIA
recorded a one-time adjustment of $3.6 million in the second
quarter of 2017 to record revenue that had previously been deferred
as of March 31, 2017. For comparison purposes, the following table
presents NUPLAZID’s pro forma quarterly net product sales
under the sell-in method for the three months ended March 31 and
June 30, 2017, respectively, if ACADIA had been able to reasonably
estimate its allowances for rebates and chargebacks from the time
of launch in May 2016. Net sales for the three months ended
September 30, 2017, as recorded under the sell-in method, are also
presented.
|
|
(in millions)
|
||
|
|
March 31,
|
June 30,
|
September 30,
|
|
|
2017
|
2017
|
2017
|
|
NUPLAZID net sales, as reported1
|
$15.3
|
$30.5
|
$35.6
|
|
Difference2
|
1.5
|
(3.6)
|
-
|
|
NUPLAZID net sales, sell-in
method3
|
$16.8
|
$26.9
|
$35.6
|
1
Represents the net
sales, as reported, for the periods presented, including the three
months ended March 31, 2017 utilizing the sell-through revenue
recognition method and the three months ended June 30, 2017
utilizing the sell-in revenue recognition method together with
one-time recognition of previously deferred revenue as a result of
the impact of the transition to the sell-in method during the three
months ended June 30, 2017.
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.
3
Represents pro
forma results for the three months ended March 31 and June 30,
2017. Results for the three months ended September 30, 2017 are as
reported.
Conference Call and Webcast Information
ACADIA
management will review its third 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
8898709). A telephone replay of the conference call may be accessed
through November 21, 2017 by dialing 855-859-2056 for callers in
the U.S. or Canada and 404-537-3406 for international callers
(reference passcode 8898709). 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
November 21, 2017.
About NUPLAZID®
(pimavanserin)
NUPLAZID
is the first and only FDA-approved treatment for hallucinations and
delusions associated with Parkinson’s disease (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 full-year 2017
NUPLAZID net sales; the benefits to be derived from NUPLAZID
(pimavanserin); and whether NUPLAZID will provide an important
benefit to patients with dementia-related 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
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)
|
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
Revenues
|
|
|
|
|
|
Product
sales, net
|
$35,578
|
$5,268
|
$81,339
|
$5,365
|
|
Collaborative
revenue
|
—
|
—
|
—
|
4
|
|
Total
revenues
|
35,578
|
5,268
|
81,339
|
5,369
|
|
Operating expenses
|
|
|
|
|
|
Cost
of product sales
|
2,135
|
845
|
6,622
|
1,371
|
|
License
fees and royalties
|
1,078
|
475
|
2,735
|
723
|
|
Research
and development
|
36,421
|
25,813
|
106,010
|
69,066
|
|
Selling,
general and administrative
|
62,255
|
50,534
|
189,523
|
128,793
|
|
Total
operating expenses
|
101,889
|
77,667
|
304,890
|
199,953
|
|
Loss
from operations
|
(66,311)
|
(72,399)
|
(223,551)
|
(194,584)
|
|
Interest
income, net
|
1,063
|
786
|
3,019
|
1,887
|
|
Net
loss
|
$(65,248)
|
$(71,613)
|
$(220,532)
|
$(192,697)
|
|
Net
loss per common share, basic and diluted
|
$(0.53)
|
$(0.61)
|
$(1.81)
|
$(1.69)
|
|
Weighted
average common shares outstanding, basic and diluted
|
122,484
|
117,497
|
122,089
|
114,063
|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
September 30,
2017
|
December 31,
2016
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Cash,
cash equivalents and investment securities
|
$366,625
|
$529,036
|
|
Accounts
receivable, net
|
14,221
|
5,903
|
|
Interest
and other receivables
|
1,033
|
1,237
|
|
Inventory
|
5,536
|
4,175
|
|
Prepaid
expenses
|
14,557
|
7,546
|
|
Total
current assets
|
401,972
|
547,897
|
|
Property
and equipment, net
|
2,991
|
3,081
|
|
Intangible
assets, net
|
5,907
|
7,015
|
|
Restricted
cash
|
2,475
|
2,375
|
|
Other
assets
|
369
|
785
|
|
Total
assets
|
$413,714
|
$561,153
|
|
Liabilities and stockholders’ equity
|
|
|
|
Accounts
payable
|
$2,962
|
$3,912
|
|
Accrued
liabilities
|
33,181
|
36,029
|
|
Deferred
revenue
|
—
|
2,644
|
|
Total
current liabilities
|
36,143
|
42,585
|
|
Long-term
liabilities
|
245
|
157
|
|
Total
liabilities
|
36,388
|
42,742
|
|
Total
stockholders’ equity
|
377,326
|
518,411
|
|
Total
liabilities and stockholders’ equity
|
$413,714
|
$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