- Net revenue for the first quarter of 2017 of $15.3 million, an increase of 28% from the fourth quarter of 2016.
- NUPLAZID (pimavanserin) available on Medicare formularies for the treatment of Parkinson's disease psychosis (PD Psychosis); commercial coverage decisions grew to over 90% of commercial lives.
- Expanded penetration into the long-term care market with 25 additional long-term care sales specialists; ACADIA currently has approximately 155 total sales specialists.
- Continued to execute on broad clinical development program with ongoing studies in Alzheimer's disease agitation, schizophrenia inadequate response, schizophrenia negative symptoms, and major depressive disorder.
- Plan to advance Alzheimer's disease psychosis (AD Psychosis) program into Phase III in second half of 2017.
- Presented data on NUPLAZID in PD Psychosis at the American Association for Geriatric Psychiatry Annual Meeting.
- Appointed Michael J. Yang as Executive Vice President, Chief Commercial Officer.
|ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited)|
|Three Months Ended March 31,|
|Product sales, net||$||15,286||$||—|
|Cost of product sales||2,263||—|
|License fees and royalties||675||—|
|Research and development||35,409||22,775|
|Selling, general and administrative||65,745||27,491|
|Total operating expenses||104,092||50,266|
|Loss from operations||(88,806||)||(50,262||)|
|Interest income, net||963||500|
|Net loss per common share, basic and diluted||$||(0.72||)||$||(0.45||)|
|Weighted average common shares outstanding, basic and diluted||121,651||111,346|
|ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)|
|March 31, 2017||December 31, 2016|
|Cash, cash equivalents, and investment securities||$||469,481||$||529,036|
|Accounts receivable, net||7,660||5,903|
|Interest and other receivables||1,859||1,237|
|Total current assets||489,753||547,897|
|Property and equipment, net||3,471||3,081|
|Intangible assets, net||6,646||7,015|
|Liabilities and stockholders' equity|
|Total current liabilities||45,265||42,585|
|Total stockholders' equity||457,524||518,411|
|Total liabilities and stockholders' equity||$||503,013||$||561,153|
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.