|Pro Forma Reconciliation of Sell-Through to Sell-In Method|
|(in millions)||Three Months Ended|
|June 30,||September 30,||December 31,||March 31,||June 30,|
|NUPLAZID net sales, as reported 1||$||0.1||$||5.3||$||12.0||$||15.3||$||30.5|
|Pro forma NUPLAZID net sales, sell-in method||$||0.5||$||6.5||$||12.5||$||16.8||$||26.9|
|1||Includes the net sales as previously reported for the quarterly periods through March 31, 2017 utilizing the sell-through revenue recognition method.|
|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.|
- Conducted End-of-Phase II meeting with the FDA on the Alzheimer's disease psychosis (AD Psychosis) program.
- Abstract of Phase II data with pimavanserin for AD Psychosis was accepted for presentation at the Clinical Trials on Alzheimer's Disease meeting in early November 2017.
- Expanded penetration into the long-term care market with the deployment of an additional 25 long-term care specialists; ACADIA currently has approximately 155 total sales specialists.
- NUPLAZID nominated for the 11 th Annual Prix Galien Award for Best Pharmaceutical Agent.
- ACADIA named to Forbes Magazine's List of World's Most Innovative Growth Companies.
- Continue to advance broad clinical development program with ongoing studies in Alzheimer's disease agitation, schizophrenia inadequate response, schizophrenia negative symptoms, and major depressive disorder.
|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,|
|Product sales, net||$||30,475||$||97||$||45,761||$||97|
|Cost of product sales||2,224||526||4,487||526|
|License fees and royalties||982||248||1,657||248|
|Research and development||34,180||20,478||69,589||43,253|
|Selling, general and administrative||61,523||50,768||127,268||78,259|
|Total operating expenses||98,909||72,020||203,001||122,286|
|Loss from operations||(68,434||)||(71,923||)||(157,240||)||(122,185||)|
|Interest income, net||993||601||1,956||1,101|
|Net loss per common share, basic and diluted||$||(0.55||)||$||(0.63||)||$||(1.27||)||$||(1.08||)|
|Weighted average common shares outstanding, basic and diluted||122,122||113,308||121,888||112,327|
|ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)|
|June 30, 2017||December 31, 2016|
|Cash, cash equivalents and investments||$||417,320||$||529,036|
|Accounts receivable, net||11,594||5,903|
|Interest and other receivables||784||1,237|
|Total current assets||443,745||547,897|
|Property and equipment, net||3,296||3,081|
|Intangible assets, net||6,277||7,015|
|Liabilities and stockholders' equity|
|Total current liabilities||40,913||42,585|
|Total stockholders' equity||415,140||518,411|
|Total liabilities and stockholders' equity||$||456,315||$||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.