ACADIA Pharmaceuticals Reports Third Quarter 2018 Financial Results
-Third Quarter Net Sales Grew to
-Recently Announced Positive Top-line Results from the Phase 2 CLARITY Trial of Pimavanserin for Adjunctive Treatment for Major Depressive Disorder
-FDA Issued Statement Reaffirming the Positive Benefit-Risk Profile of NUPLAZID® for Patients with Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
-Launched New Dosing Formulation and Strength of NUPLAZID
“We made significant progress this quarter. On the heels of launching
our new 34 mg capsule for NUPLAZID, the
Announced positive top-line results from the Phase 2 CLARITY trial of
pimavanserin for adjunctive treatment in patients with major
depressive disorder (MDD).
- Pimavanserin met the pre-specified primary endpoint of the equally-weighted average results of Stage 1 and Stage 2 by significantly reducing 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to placebo (p=0.039). In Stage 1, an all-comer parallel comparison to placebo treatment period, pimavanserin showed a highly significant improvement over placebo (p=0.0003; Effect size=0.626).
- Pimavanserin also demonstrated statistically significant reductions compared to placebo in the pre-specified key secondary endpoint, the Sheehan Disability Scale (SDS), a patient self-assessment of work, family, and social activities (p=0.004).
- Positive results were also observed on seven additional pre-specified secondary endpoints including responder rate, improvement in sexual function, and reduction in daytime sleepiness.
Additional details from the Phase 2 CLARITY results are included
in the press release issued by the Company on
October 31, 2018.
The Company plans to meet with the
FDAand initiate a Phase 3 program for pimavanserin as an adjunctive treatment for MDD in the first half of 2019.
FDAissued a public statement reaffirming the positive benefit-risk profile of NUPLAZID for patients with hallucinations and delusions associated with Parkinson’s disease psychosis.
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. The Company plans to initiate a Phase 3 trial with trofinetide for Rett syndrome in the second half of 2019.
- Launched a new 34 mg single capsule formulation of NUPLAZID to treat patients living with hallucinations and delusions associated with Parkinson’s disease psychosis.
Robert Kaper, M.D., as Senior Vice President, Global Head of Medical Affairs, Eliseo Salinas, M.D. M.Sc., as Senior Vice President, Chief Scientific Officer and Head of External Innovation, and Elena Ridloff, CFA, Senior Vice President of Investor Relations, as Interim Chief Financial Officer.
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
ACADIA is updating its 2018 NUPLAZID net sales guidance to be between
ACADIA is updating its guidance for 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 third quarter financial results and operations via conference call and webcast today at
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only
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 ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for fourth 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.
Three Months Ended
Nine Months Ended
|Product sales, net||$||58,305||$||35,578||$||164,236||$||81,339|
|Cost of product sales, license fees and royalties||5,375||3,213||13,938||9,357|
|Research and development||53,112||36,421||138,980||106,010|
|Selling, general and administrative||61,089||61,588||191,487||188,373|
|Total operating expenses||119,576||101,222||344,405||303,740|
|Loss from operations||(61,271||)||(65,644||)||(180,169||)||(222,401||)|
|Interest income, net||1,229||1,063||3,678||3,019|
|Loss before income taxes||(61,762||)||(64,581||)||(178,458||)||(219,382||)|
|Income tax expense||376||667||1,242||1,150|
|Net loss per common share, basic and diluted||$||(0.50||)||$||(0.53||)||$||(1.44||)||$||(1.81||)|
|Weighted average common shares outstanding, basic and diluted||125,009||122,484||124,883||122,089|
ACADIA PHARMACEUTICALS INC.
|Cash, cash equivalents and investment securities||$||214,136||$||341,342|
|Accounts receivable, net||19,958||17,343|
|Interest and other receivables||724||1,087|
|Total current assets||254,116||373,477|
|Property and equipment, net||3,372||2,662|
|Intangible assets, net||4,431||5,538|
|Liabilities and stockholders’ equity|
|Total current liabilities||41,807||49,030|
|Total stockholders’ equity||223,440||335,285|
|Total liabilities and stockholders’ equity||$||266,456||$||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.