ACADIA Pharmaceuticals Reports Second Quarter 2018 Financial Results
–Second Quarter Net Sales Grew to
–Announced FDA Approval of New Dosing Formulation and Strength of NUPLAZID® (Pimavanserin)
–Expanded ACADIA’s Pipeline in Central Nervous System Disorders with
Exclusive License Agreement for the
“In the second quarter, NUPLAZID delivered 17% revenue growth and 3%
sequential volume growth. We remain focused on our initiatives to
provide physicians, patients and caregivers access to NUPLAZID’s robust
safety and efficacy data and to improve the lives of patients living
with Parkinson’s disease psychosis,” said
Recent Highlights
-
Announced an exclusive license agreement with
Neuren Pharmaceuticals (ASX: NEU) for the North American development and commercialization of trofinetide for all indications, including Rett syndrome, a rare neurodevelopmental CNS disorder. Trofinetide is a novel synthetic analog of the amino-terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by reducing neuroinflammation and supporting synaptic function. -
Announced
FDA approval of a new 34 mg single capsule formulation of NUPLAZID to help in the treatment of patients living with hallucinations and delusions associated with Parkinson’s disease psychosis. - Completed enrollment in the Phase 2 CLARITY study assessing pimavanserin as a potential adjunctive treatment for major depressive disorder.
-
Appointed
Austin D. Kim as Executive Vice President, General Counsel and Secretary.
Financial Results
Revenue
Net sales of NUPLAZID were
Research and Development
Research and development expenses
for the three months ended
Selling, General and Administrative
Selling, general and
administrative expenses for the three months ended
Net Loss
For the three months ended
Cash and Investments
At June 30, 2018, ACADIA’s cash, cash
equivalents and investment securities totaled
Financial Guidance
ACADIA is lowering its 2018 NUPLAZID net sales guidance to be between
For the third quarter of 2018, ACADIA expects NUPLAZID net sales to be
between
ACADIA is lowering its guidance for its year end 2018 cash, cash
equivalents and investment securities on its balance sheet to be between
Conference Call and Webcast Information
ACADIA management
will review its first quarter financial results and operations via
conference call and webcast today at
About NUPLAZID® (pimavanserin)
NUPLAZID
is the first FDA-approved treatment for hallucinations and delusions
associated with Parkinson’s disease psychosis. NUPLAZID is a
non-dopaminergic, selective serotonin inverse agonist preferentially
targeting 5-HT2A receptors that are thought to play an
important role in Parkinson’s disease psychosis. NUPLAZID is an oral
medicine taken once a day with a recommended dose of 34 mg. ACADIA
discovered and developed this new chemical entity and holds worldwide
rights to develop and commercialize NUPLAZID.
About
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 has developed and is commercializing the first and
only medicine approved for the treatment of hallucinations and delusions
associated with Parkinson’s disease psychosis. In addition, ACADIA has
ongoing clinical development efforts in additional areas with
significant unmet need including dementia-related psychosis,
schizophrenia inadequate response, schizophrenia-negative symptoms,
major depressive disorder and Rett syndrome. This press release and
further information about ACADIA can be found at: www.acadia-pharm.com.
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 potential opportunity for future growth in sales of
NUPLAZID, including through sales of new dosages and forms; the timing
of results from our study in major depressive disorder and the timing of
other ongoing clinical studies; the development and commercialization of
trofinetide; and guidance for third quarter NUPLAZID net sales and
certain expense line items. 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
|
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, | |||||||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||||||||||
| Revenues | ||||||||||||||||||||||||
| Product sales, net | $ | 57,063 | $ | 30,475 | $ | 105,931 | $ | 45,761 | ||||||||||||||||
| Total revenues | 57,063 | 30,475 | 105,931 | 45,761 | ||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||
| Cost of product sales, license fees and royalties | 5,078 | 3,206 | 8,563 | 6,144 | ||||||||||||||||||||
| Research and development | 46,592 | 34,180 | 85,868 | 69,589 | ||||||||||||||||||||
| Selling, general and administrative | 69,472 | 61,125 | 130,398 | 126,785 | ||||||||||||||||||||
| Total operating expenses | 121,142 | 98,511 | 224,829 | 202,518 | ||||||||||||||||||||
| Loss from operations | (64,079 | ) | (68,036 | ) | (118,898 | ) | (156,757 | ) | ||||||||||||||||
| Interest income, net | 1,279 | 993 | 2,449 | 1,956 | ||||||||||||||||||||
| Other expense | (247 | ) | — | (247 | ) | — | ||||||||||||||||||
| Loss before income taxes | (63,047 | ) | (67,043 | ) | (116,696 | ) | (154,801 | ) | ||||||||||||||||
| Income tax expense | 219 | 398 | 866 | 483 | ||||||||||||||||||||
| Net loss | $ | (63,266 | ) | $ | (67,441 | ) | $ | (117,562 | ) | $ | (155,284 | ) | ||||||||||||
| Net loss per common share, basic and diluted | $ | (0.51 | ) | $ | (0.55 | ) | $ | (0.94 | ) | $ | (1.27 | ) | ||||||||||||
| Weighted average common shares outstanding, basic and diluted | 124,910 | 122,122 | 124,819 | 121,888 | ||||||||||||||||||||
|
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
|||||||||||||||||
|
June 30,
2018 |
December 31,
2017 |
||||||||||||||||
| (unaudited) | |||||||||||||||||
| Assets | |||||||||||||||||
| Cash, cash equivalents and investment securities | $ | 256,855 | $ | 341,342 | |||||||||||||
| Accounts receivable, net | 25,696 | 17,343 | |||||||||||||||
| Interest and other receivables | 986 | 1,087 | |||||||||||||||
| Inventory | 4,737 | 5,248 | |||||||||||||||
| Prepaid expenses | 12,822 | 8,457 | |||||||||||||||
| Total current assets | 301,096 | 373,477 | |||||||||||||||
| Property and equipment, net | 2,760 | 2,662 | |||||||||||||||
| Intangible assets, net | 4,800 | 5,538 | |||||||||||||||
| Restricted cash | 3,111 | 2,475 | |||||||||||||||
| Other assets | 3,193 | 354 | |||||||||||||||
| Total assets | $ | 314,960 | $ | 384,506 | |||||||||||||
| Liabilities and stockholders’ equity | |||||||||||||||||
| Accounts payable | $ | 3,333 | $ | 8,786 | |||||||||||||
| Accrued liabilities | 45,881 | 40,244 | |||||||||||||||
| Total current liabilities | 49,214 | 49,030 | |||||||||||||||
| Long-term liabilities | 1,026 | 191 | |||||||||||||||
| Total liabilities | 50,240 | 49,221 | |||||||||||||||
| Total stockholders’ equity | 264,720 | 335,285 | |||||||||||||||
| Total liabilities and stockholders’ equity | $ | 314,960 | $ | 384,506 | |||||||||||||
Important Safety Information and Indication for NUPLAZID (pimavanserin)
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: Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily. Coadministration with strong CYP3A4 inducers may reduce NUPLAZID exposure. Monitor patients for reduced efficacy and an increase in NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg taken orally once daily, without titration.
NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg tablets.
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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Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
Elena
Ridloff, CFA
(858) 558-2871
ir@acadia-pharm.com
or
Media
Contact:
Taft Communications
Bob Laverty
(609)
558-5570
bob@taftcommunications.com