Second Quarter Net Sales Grew to $30.5 Million
Including $3.6 Million From Transition to Sell-In Method of
Accounting
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
(in millions)
Three Months Ended
June 30, September 30, December
31, March 31, June 30, 2016
2016 2016 2017 2017 NUPLAZID net
sales, as reported1 $ 0.1 $ 5.3 $ 12.0 $ 15.3 $ 30.5 Difference2
0.4 1.2 0.5 1.5 (3.6 )
Pro forma NUPLAZID net sales, sell-in
method
$ 0.5 $ 6.5 $ 12.5 $ 16.8 $ 26.9
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.
- 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.
- NUPLAZID nominated for the 11th Annual
Prix Galien Award for Best Pharmaceutical Agent.
- ACADIA named to Forbes Magazine’s List
of World’s Most Innovative Growth Companies.
- 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
RevenueNet 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 DevelopmentResearch 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 AdministrativeSelling, 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 LossFor 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 in 2016. 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 InvestmentsAt 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 GuidanceACADIA expects that full-year NUPLAZID
net sales for 2017 will be between $105 million and $115
million.
Conference Call and Webcast InformationACADIA 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 PharmaceuticalsACADIA 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 StatementsStatements 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)
Three Months Ended June 30,
Six Months Ended June 30, 2017 2016
2017 2016 Revenues Product sales, net $
30,475
$
97
$
45,761 $ 97 Collaborative revenue — — —
4 Total revenues 30,475 97 45,761 101
Operating expenses
Cost of product sales 2,224 526 4,487 526 License fees and
royalties 982 248 1,657 248 Research and development 34,180 20,478
69,589 43,253 Selling, general and administrative 61,523
50,768 127,268 78,259 Total operating expenses
98,909 72,020 203,001 122,286 Loss from
operations (68,434 ) (71,923 ) (157,240 ) (122,185 ) Interest
income, net 993 601 1,956 1,101 Net
loss $ (67,441 ) $ (71,322 ) $ (155,284 ) $ (121,084 ) Net loss per
common share, basic and diluted $ (0.55 ) $ (0.63 ) $ (1.27 ) $
(1.08 ) Weighted average common shares outstanding, basic and
diluted 122,122 113,308 121,888 112,327
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
June 30,
2017
December 31,
2016
(unaudited)
Assets Cash, cash equivalents and investments $
417,320 $ 529,036 Accounts receivable, net 11,594 5,903 Interest
and other receivables 784 1,237 Inventory 6,003 4,175 Prepaid
expenses 8,044 7,546 Total current assets 443,745
547,897 Property and equipment, net 3,296 3,081 Intangible assets,
net 6,277 7,015 Restricted cash 2,475 2,375 Other assets 522
785 Total assets $ 456,315 $ 561,153
Liabilities and
stockholders’ equity Accounts payable $ 3,588 $ 3,912 Accrued
liabilities 37,325 36,029 Deferred revenue — 2,644
Total current liabilities 40,913 42,585 Long-term liabilities
262 157 Total liabilities 41,175 42,742 Total
stockholders’ equity 415,140 518,411 Total
liabilities and stockholders’ equity $ 456,315 $ 561,153
Important Safety Information and
Indication for NUPLAZID (pimavanserin)
tabletsWARNING: INCREASED MORTALITY IN ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSISElderly 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170808006350/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy,
858-558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsBob Laverty,
609-558-5570bob@taftcommunications.com
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