– Third Quarter Net Sales Grew to $35.6
Million
– Company Raises Annual 2017 Net Sales Guidance
to Between $124 Million and $127 Million
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171107006591/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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