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
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.
FDAapproval 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.
Austin D. Kimas Executive Vice President, General Counsel and Secretary.
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
For the three months ended
Cash and Investments
At June 30, 2018, ACADIA’s cash, cash equivalents and investment securities totaled
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
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.
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.
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)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Product sales, net||$||57,063||$||30,475||$||105,931||$||45,761|
|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|
|Loss before income taxes||(63,047||)||(67,043||)||(116,696||)||(154,801||)|
|Income tax expense||219||398||866||483|
|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
|Cash, cash equivalents and investment securities||$||256,855||$||341,342|
|Accounts receivable, net||25,696||17,343|
|Interest and other receivables||986||1,087|
|Total current assets||301,096||373,477|
|Property and equipment, net||2,760||2,662|
|Intangible assets, net||4,800||5,538|
|Liabilities and stockholders’ equity|
|Total current liabilities||49,214||49,030|
|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
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.